Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study treatment period and through 4 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraceptionXx_NEWLINE_xXWomen of childbearing age should avoid becoming pregnant while taking any mTOR inhibitor including MLN0128 (TAK-228)\r\n*Female patients must:\r\n** Be postmenopausal for at least 1 year before the screening visit, OR\r\n** Be surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g., United States product insert [USPI], summary of product characteristics [SmPC], etc.;]) after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Male patients, even if surgically sterilized (i.e., status postvasectomy), must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** AND agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drugXx_NEWLINE_xXtotal abstinence (if it is their preferred and usual lifestyle)Xx_NEWLINE_xXNegative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year; women must use an effective method of contraception from 14 days prior to randomization, throughout the treatment period, and for at least 6 months after the last dose of study treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception); hormonal-based methods (e.g., oral contraceptives) are NOT permitted as contraceptionXx_NEWLINE_xXMale subjects agree to remain abstinent or use a condom plus an additional contraceptive method that result in a failure rate of < 1% per year during sexual contact with a female of childbearing potential while participating in the study, during dose interruptions, and for 31 weeks following the last dose of the study treatment, even if he has undergone a successful vasectomy; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence and withdrawal are not acceptableXx_NEWLINE_xXMen, even if surgically sterilized (i.e. status post-vasectomy), who are sexually active with WOCBP must agree to follow instructions for effective barrier contraception from the time of signing consent and until 4 months after last dose of protocol-indicated treatment; periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXFor women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devicesXx_NEWLINE_xXFor men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXFemales of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through 28 days after the last dose of study drug unless patient is practicing true abstinence; acceptable forms of effective contraception include:\r\n* Oral, injected or implanted hormonal methods of contraception\r\n* Tubal ligation\r\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository\r\n* Male sterilization (defined as complete retrograde ejaculation or the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)\r\n* True abstinence: when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients must meet one of the following criteria:\r\n* Postmenopausal for at least 1 year prior to registration \r\n* Surgically sterile\r\n* Of childbearing potential and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug\r\n* Of childbearing potential and agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit\r\n* Are surgically sterile\r\n* If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [e.g., United States product insert (USPI), summary of product characteristics (SmPC), etc,]) after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drugXx_NEWLINE_xXNon-pregnant; women of childbearing potential must have a negative pregnancy test (human chorionic gonadotropin [HCG] serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy; female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner; non-sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below\r\n* Female subjects must meet one of the following:\r\n** Natural postmenopausal before the screening visit defined as no menses at any time in the preceding 12 consecutive months, or\r\n** Prior bilateral oophorectomy or bilateral tubal ligation, or\r\n** If they are of childbearing potential, agree to practice two effective methods of contraception per discussion with the treating physicians from the time of signing of the informed consent form through three months after the last dose of study drug, or\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable contraception methods)\r\n* Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:\r\n** Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, or\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXAgree to use two reliable forms of contraception simultaneously or to practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting CC-122; 2) while taking CC-122; 3) during dose interruptions; and 4) for at least 28 days after the last dose of CC-122 as specified in the Pregnancy Prevention and Risk Management Plan (PPRMP)Xx_NEWLINE_xXPractice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a FCBP for at least 12 months after the last dose of rituximab.Xx_NEWLINE_xXThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Negative serum pregnancy test done ? 7 days prior to registration, for women of childbearing potential onlyXx_NEWLINE_xXtotal abstinence (if it is their preferred and usual lifestyle)Xx_NEWLINE_xXFemale subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) through 90 days after the last dose of maintenance therapy (see Section 2.6.2 for definition of postmenopausal).Xx_NEWLINE_xXMale subjects (even if surgically sterilized) must agree to one of the following: practice effective barrier contraception (see Section 2.6.4.1 for list of barrier methods), or practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of from the time of signing the informed consent through 90 days after last dose of maintenance therapy.Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patientXx_NEWLINE_xXMen must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 90 days after the last dose of study drug OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXPractice true abstinence orXx_NEWLINE_xXMale subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following protocol discontinuation, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients must meet one of the following:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXNon-pregnant and non-lactating\r\n* Female patients who:\r\n** Are postmenopausal for at least 1 year before the screening visit, OR\r\n** Are surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXWilling to follow strict birth control measures as suggested by the study\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXWilling to follow strict birth control measures;\r\n* Female patients: If they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 120 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who: Are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [e.g., United Surgical Partners International (USPI), summary of product characteristics (SmPC), etc,]) after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug.Xx_NEWLINE_xXNote: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subjectXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional (barrier) of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXFemale and male participants of childbearing potential must agree to use an adequate method of contraception; contraception is required starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXWomen of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment. Adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXTotal abstinence (if it is their preferred and usual lifestyle)Xx_NEWLINE_xXWomen of child-bearing potential (WOCBP-defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must\r\n* Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study medication therapy (including dose interruptions), and for 6 months after last dose of study medication\r\n* Have a negative serum or urine pregnancy test (beta - human chorionic gonadotropin [hCG]) result at screening - this applies even if the subject practices true abstinence from heterosexual contact\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFor men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period\r\n* Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy\r\n* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXPersons of childbearing potential, agree to one of the following:\r\n* Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXPersons able to father a child: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXPatients of reproductive potential must be willing to practice highly effective methods of contraception throughout the study and for 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle of the patient.Xx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)Xx_NEWLINE_xXFemale patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception; MUST have a negative serum or urine pregnancy test within 7 days of initiating protocol treatment unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; should a woman become pregnant or suspect she is pregnant, she should inform her treatment physician immediately; male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g. calendar, ovulation, symptothermal, post ovulation methods for the female partner] and withdrawal are not acceptable methods of contraception, or agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXWilling to follow strict birth control measures\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients must be:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential\r\n** Agree to practice 1 highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy) must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXAdequate contraception as follows:\r\n* For women:\r\n** Postmenopausal for at least 1 year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 effective method of contraception, and 1 additional (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States Package Insert (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXFemale patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods]), and latex or non-latex condom with or without a spermicidal agent, diaphragm with spermicide; cervical cap with a spermicide; sponge with a spermicideXx_NEWLINE_xXA woman of childbearing potential (WOCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months); female patients who are WOCBP must agree to practice:\r\n* 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* True abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* A WOCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting therapy with Revlimid; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS programXx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMen must agree to practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation of study therapy, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemales of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:\r\n* Either commit to true abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]) from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product (IP) therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations\r\nfollowing the last dose of IP; and\r\n* Have a negative serum pregnancy test (beta-hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, as per clinical judgement of the investigator, and after the end of study therapy; this applies even if the subject practices true abstinence from heterosexual contactXx_NEWLINE_xXFemale subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; this applies even if the subject practices true abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]) from heterosexual contact; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be requiredXx_NEWLINE_xXShould a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; females of child-bearing potential (defined as a sexually mature woman who [1] has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or [2] has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:\r\n* Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product (IP) therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and\r\n* Have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) result at screening; this applies even if the subject practices true abstinence from heterosexual contact\r\n** True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception])Xx_NEWLINE_xXFemale patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 1 effective method of contraception and one additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated bu local labeling [eg, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used togetherXx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used together; agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFor women:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFor men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception)\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXCERITINIB EXCLUSION CRITERIA: Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after the last dose of capmatinib; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatmentXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFor men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXSexually active subjects and their partners must agree to use medically accepted methods of contraception\r\n* For women:\r\n** Postmenopausal for at least 1 year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** Agree to practice 1 effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc.] after the last dose of study drug, OR\r\n**Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* For men:\r\n** Even if surgically sterilized (i.e., status post-vasectomy), they must agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXPatients who: a) are postmenopausal for at least 1 year before the screening visit, OR; b) are surgically sterile, OR; c) if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR; d) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: e) agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR; f) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXWomen of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patientXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).Xx_NEWLINE_xXMale subjects must agree to use one of the contraception methods listed below; this criterion must be followed from the time of the first dose of study medication until 4 weeks after the last dose of study medication; however, it is advised that contraception be used for a total of 16 weeks following the last dose; methods: a) abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject; periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; b) condom (during non-vaginal intercourse with any partner - male or female) OR c) condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) (during sexual intercourse with a female)Xx_NEWLINE_xXTotal abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXWilling to follow strict birth control measures as suggested below\r\n* Female patients: if they are of childbearing potential (except if postmenopausal for at least 1 year before the screening visit, OR are surgically sterile), agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXTotal abstinence from sexual relations for the duration of the treatment when applicable to the lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXTotal abstinence (if it is their preferred and usual lifestyle);Xx_NEWLINE_xXWilling to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXTotal abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)Xx_NEWLINE_xXFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 180 days after the last dose of study treatment. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXFemales of child-bearing potential (defined as a sexually mature woman who [1] has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or [2] has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:\r\n* Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use and be able to comply with effective contraception without interruption 28 days prior to starting investigation product (IP) therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and\r\n* Have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) result at screening and agree to ongoing pregnancy testing prior to each treatment and after the end of study therapy; this applies even if the subject practices true abstinence from heterosexual contact\r\n* Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy\r\n* NOTE: True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXtrue sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXWilling to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post vasectomy), have to either: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study treatment, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients have to fulfill one of the following: \r\n* Be postmenopausal for at least 1 year before the screening visit, OR\r\n* Be surgically sterile, OR \r\n* If of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study treatment\r\n* Patients who are using oral contraceptives as a method of contraception, and are sexually active, should use another effective contraceptive method, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXTotal abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are NOT acceptable methods of contraceptionXx_NEWLINE_xXAgree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.). Male participants, even if surgically sterilized (ie, status post vasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXRemain abstinent or use a condom as defined in Section 8.3.8.4.2, starting at the planned first dose of IP until 30 days following the last dose of IP. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXhas not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXRefrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXMale subjects must: a. Practice true abstinence* or agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study for at least 3 months following the last dose of IP. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].Xx_NEWLINE_xXA woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXExamples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.). Male participants, even if surgically sterilized (ie, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.).Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).Xx_NEWLINE_xXFemale patients who: \r\n* Are postmenopausal for at least 1 year before the screening visit, OR \r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemales and males must practice true abstinence or agree to contraceptive methods throughout the study, and for up to 8 weeks following the last dose of CC 90002.Xx_NEWLINE_xXMen must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 154 days after the last dose of lenalidomide (Revlimid) or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Men who are sexually active with women who are of childbearing potential must adhere to contraception for a period of 5 half-lives plus 90 days for a total of 7 months after their last dose of nivolumabXx_NEWLINE_xXFemale patients who: \r\n* Are postmenopausal for at least 24 months before the screening visit, OR\r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), who: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale participants must practice true abstinence* (which must be reviewed on a monthly basis) or agree to the use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months following investigational product discontinuation (or longer if required by local requirements), even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the participant. Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse; periodic abstinence (calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or\r\n* Agree to completely abstain from heterosexual intercourse; periodic abstinence (calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice two effective contraception measures during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXPatients of childbearing or child fathering potential must use medically acceptable form(s) of birth control as stated within the pomalidomide Pregnancy Risk Minimization Plan, which includes abstinence, while being treated on this study; true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* Are of childbearing potential, \r\n** Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients of childbearing potential [defined as all female patients ? 12 years old or who have reached menarche, whichever occurs first] must have both of the following: a. Agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study medication or for a longer period if required by regulations. i. True abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. ii. Acceptable contraceptive methods include: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) including at least one barrier method. b. Have negative serum pregnancy test result at screening confirmed by negative urine pregnancy dipstick within 72 hours prior to first dose of Investigational Product (IP) (if serum test occurred > 72 hours from first dose); pregnancy test with sensitivity of at least 25 mIU/mL.Xx_NEWLINE_xXIf they are of childbearing potential:\r\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)Xx_NEWLINE_xXFemale subjects who are postmenopausal for at least 1 year prior to screening. For women of child-bearing potential agree to practice 2 effective methods of contraception, or agree to practice true abstinenceXx_NEWLINE_xXNegative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year; fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, and must also agree to ongoing pregnancy testing; must also adhere to the guidelines of the lenalidomide pregnancy prevention programXx_NEWLINE_xXWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after midostaurin medication; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\r\n* Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subjectXx_NEWLINE_xXFemale patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent, during study treatment and for 90 days after the last dose of study treatment, AND \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study treatment, OR \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test before initiation of study treatment and must also use highly effective methods of contraception while enrolled in the study. The use of highly effective contraception should continue for at least 14 days after the last dose of study treatment or until the last day of TFR/TFR-2, or for the duration of a monthly cycle of oral contraception, whichever is longer. Acceptable forms of highly effective contraception methods include: a. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception and male/female sterilization defined as:Xx_NEWLINE_xXFemale participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participantXx_NEWLINE_xXMale participants who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participantXx_NEWLINE_xXIf they were of childbearing potential must have: had a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10 to 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide; either agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR begun 2 reliable methods of birth control (1 highly effective method and 1 additional effective method) at the same time, at least 28 days before starting study treatment through 90 days after the last dose of study treatment; and agreed to ongoing pregnancy testing AND must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other participants who were not using commercial supplies). Male patients, even if surgically sterilized (ie, status postvasectomy), who:Xx_NEWLINE_xXAgreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) ORXx_NEWLINE_xXFemale patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 3 months after the last dose of study drug or agree to practice true abstinenceXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); if patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (3-HCG) test within 14 days prior to registration and consent to ongoing pregnancy testing during the course of the studyXx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXA highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly. Acceptable methods of contraception are described in Table 4.2.1-1. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraceptionXx_NEWLINE_xXComplete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.Xx_NEWLINE_xXPeriodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.Xx_NEWLINE_xXTotal abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (i.e., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXFemale patients must be:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXWomen of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment male sterilization (at least 6 months prior to screening)Xx_NEWLINE_xXFemale patients who: are postmenopausal for at least 1 year, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, from the time of signing the informed consent through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception;) male patients, even if surgically sterilized, must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subjectXx_NEWLINE_xXMale subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Note: Periodic abstinence (e.g, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFemales of child-bearing potential (defined as a sexually mature woman who [1] has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or [2] has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:\r\n* Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception (=< 1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 90 days following treatment completion; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy; this applies even if the subject practices true abstinence from heterosexual contactXx_NEWLINE_xXComplete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.Xx_NEWLINE_xXPeriodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.Xx_NEWLINE_xXTotal abstinence (if this is the usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. (Subject must agree to use contraception should they become sexually active while on the study.)Xx_NEWLINE_xXIf they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception).Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception).Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xXFemale patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinenceXx_NEWLINE_xXMale patients who agree to practice effective barrier contraception or agree to practice true abstinenceXx_NEWLINE_xXtotal abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable;Xx_NEWLINE_xXFemale patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception through 90 days after the last dose of study drug or agree to practice true abstinenceXx_NEWLINE_xXFemale patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinenceXx_NEWLINE_xXMale patients who agree to practice effective barrier contraception or agree to practice true abstinenceXx_NEWLINE_xXFor women:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR - If they are of childbearing potential, agree to practice 1 effective methods of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc;]) after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)Xx_NEWLINE_xXFor men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together);\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drugXx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Male participant, even if surgically sterilized (that is, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)Xx_NEWLINE_xXWomen of child bearing potential must have a negative serum or urine pregnancy test within 7 days of registration and must agree to:\r\n* Practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 120 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc.;]) after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used togetherXx_NEWLINE_xXMale patients, even if surgically sterilized (i.e., status postvasectomy) must agree to:\r\n* Practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n* Practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient;  NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drugXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (i.e. status post-vasectomy) must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those, which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXFor all women of childbearing potential, a negative pregnancy test must be obtained at the baseline visit before starting study treatment\r\n* For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug\r\n** Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year; barrier methods must always be supplemented with the use of a spermicide\r\n* For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period\r\n** Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy\r\n** Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXFemale patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXMale patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)Xx_NEWLINE_xXTotal abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraceptionXx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (that is, status postvasectomy), who:Xx_NEWLINE_xXAgree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)Xx_NEWLINE_xX