Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for 90 days after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
DONOR: Donors must not be pregnant; donors of childbearing potential must use an effective method of contraception, including one or more of the following: intrauterine device, hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods (condom, diaphragm, or cervical cap), or abstinence from the day of signing consent through day +60 of the recipient’s allo- BMT
Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, intrauterine device [IUD], ring, condom, sponge, foam)
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.
Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use one or more of the following forms of contraception from the time of signing the informed consent form through day +100: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence; male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +100
DONOR: female and male donors must agree to use one or more forms of birth control for either themselves or their partner, as appropriate, from the time of signing the informed consent form through day +6: hormonal (i.e., oral, transdermal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence
Enrollment in the Celgene THALOMID REMS Program:\r\n* If enrolled in Arm III of this study, patient must be registered at the Celgene THALOMID REMS Program\r\n* If enrolled in Arm III of this study, patient must be willing to practice birth control as outlined in the THALOMID REMS Program from the beginning of the study until at least 4 weeks following discontinuation of thalidomide therapy; two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is chosen; contraceptive methods must include at least one highly effective method (e.g. oral contraceptive pills, injections, hormonal patches, intrauterine device [IUD], or implants), AND one additional effective barrier method (e.g. latex condom, diaphragm, cervical cap); if hormonal or IUD contraception is medically contraindicated, another highly effective method or two barrier methods must be used at the same time\r\n* Pregnancy surveillance:\r\n** Patient must have a negative in office pregnancy test sensitive to within 50 mIU/mL (serum or urine) within 24 hours of beginning thalidomide even if continuous abstinence is the preferred method of birth control\r\n** A pregnancy test must be performed weekly during the first 4 weeks of therapy and repeated monthly for patients with regular menses or every 2 weeks for patients with irregular menses\r\n** Negative pregnancy tests are valid for only 7 days\r\n** If irregular bleeding or skipped menses, pregnancy test should be performed and pregnancy counseling given\r\n** If pregnancy occurs during treatment, thalidomide must be immediately discontinued; any suspected lethal exposure must be reported immediately to Celgene Customer Care Center at 1-888-423-5346, and the patient referred to an obstetrician (OB)/gynecologist (GYN) experienced in reproductive toxicity for further evaluation and counseling
All men and women of childbearing potential must be willing to use effective contraception as determined by the principal investigator (including but not limited to abstinence, hormonal contraceptives [birth control pills, injections, or implants], intrauterine device [IUD], tubal ligation, vasectomy) from the time of enrollment to at least six months following the last dose of drug
If female and of childbearing potential, is willing to use medically acceptable contraceptive measures for the duration of the study; acceptable methods of contraception include (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as rhythm method or Plan B, sold for emergency use after unprotected sex, are not acceptable methods for routine use
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. a) Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide).
Subjects of childbearing potential must be willing to practice an approved highly effective method of birth control starting at the time of informed consent and for 1 year after the completion of the lymphodepletion regimen. Approved methods of birth control are as follows: hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation or hysterectomy; subject/partner status post vasectomy; Implantable or injectable contraceptives; and condoms plus spermicide.
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (a) appropriate method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)
For women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to the start of the study; women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of the study; medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use; if you do become pregnant during this study or if you have unprotected sex, you must inform your study physician immediately
For men who are sexually active, must agree to use a two medically acceptable forms of birth control (one of which must include a condom as a barrier method of contraception) in order to be in this study; medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide; contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use; men must also agree to inform their partner of the potential for harm to an unborn child; she should know that if pregnancy occurs, the subject will need to report it to the study doctor, and she should promptly notify her doctor; the study doctor will ask if the subject’s partner is willing to provide updates on the progress of the pregnancy and its outcome; if the subject’s partner agrees, this information will be provided to Pfizer, Inc. for safety monitoring follow-up
Male or female patients of reproductive potential who are not employing an effective method of birth control; adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide cervical/vault cap or intrauterine device), and abstinence
Pregnant or breast-feeding; female patients of child-bearing potential or female sexual partners (who are of child-bearing potential) of male patients must use at least one of the following methods of medically acceptable contraceptives: approved hormonal contraceptives (such as birth control pills, patches, implants or infusions), an intrauterine device (IUD), or a barrier method of contraception (such as a condom or diaphragm) used with spermicide; there should be no risk of transmission of a mother to her fetus after receiving intracranial PVSRIPO; as such, patients who become pregnant after receiving PVSRIPO will continue to be monitored in the same manner, i.e. per protocol, unless the assessment is contraindicated during pregnancy; partners who become pregnant will sign a Pregnant Partner Information Form and information regarding the pregnancy and its outcome may be collected
Pregnant females; breastfeeding females; and males and females of childbearing potential not willing to use two highly effective methods of birth control, one being barrier method. Intrauterine Devices (IUD) and birth control pills are not barrier methods, but are highly effective especially when combined with a barrier method (e.g. latex condom or a diaphragm or cervical cap) while taking investigational product (SY-1425) and continuing contraception use for at least 90 days after the last dose of study drug. Men/women should not donate sperm or ova during this time frame.
Women of childbearing potential in agreement to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood; this may be a period of several years; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
Females who are pregnant or breast-feeding; female patients of child-bearing potential or female sexual partners (who are of child-bearing potential) of male patients must use at least one of the following methods of medically acceptable contraceptives: approved hormonal contraceptives (such as birth control pills, patches, implants or infusions), an intrauterine device (IUD), or a barrier method of contraception (such as a condom or diaphragm) used with spermicide; as such, patients who become pregnant after receiving PVSRIPO will continue to be monitored in the same manner, i.e. per protocol, unless the assessment is contra-indicated during pregnancy; partners who become pregnant will sign a Pregnant Partner Information Form and information regarding the pregnancy and its outcome may be collected
Men must agree to use adequate contraception (abstinence, vasectomy) or female partner must use (intrauterine device [IUD], hormonal [birth control, pills, injections, or implants], tubal ligation) prior to study entry and for up to 5 months after the last dose
If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after trial; if male, use of an approved contraceptive method during the study and 6 months afterwards; females with childbearing potential must have a urine negative human chorionic gonadotropin (hCG) test within 7 days prior to the study therapy
Patients of childbearing potential (i.e., women of childbearing potential and men with female partners of childbearing potential) who are unwilling to follow strict contraception requirements (including 2 reliable methods in combination: 1 non-hormonal, highly-reliable method [diaphragm, condoms with spermicidal foam or jelly, or sterilization] plus 1 additional reliable method [birth control pills, intrauterine device, contraceptive injections, or contraceptive patches]) before entry and throughout the study, up to and including the 30-day non-treatment follow-up period
Pregnancy or lactation at the time of registration; for women of childbearing potential, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills
Women of childbearing potential and men must agree to use effective methods of birth control for the duration of the study and 6 months after; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
Women of child-bearing potential must consent to use adequate contraception during the course of the study: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use
Women of child-bearing potential must consent to use adequate contraception during the course of the study; female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use
Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate “double barrier” method of birth control (such as female use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed “birth control” pills, injections, or implants
Acceptable forms of birth control include condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility (tubal ligation or a partner that has undergone a vasectomy), or oral contraceptives, OR the subject must agree to completely abstain from heterosexual intercourse.; abstinence at certain times of the cycle only, such as during the days of ovulation, after ovulation and withdrawal are not acceptable methods of birth control
Premenopausal and using an acceptable form of birth control. Acceptable forms of birth control include: hormonal contraceptives (implantable, oral, patch) used for ? 2 months prior to screening or double barrier methods (any combination of two of the following: intrauterine device [IUD], male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). All premenopausal females must have a negative urine or serum pregnancy test at screening and on Day 1 prior to first PRTX-100 treatment.
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 30 days following the last dose of study drug; effective methods of birth control include: birth control pills, shots, implants (placed under the skin by a health care provider) or patches (placed on the skin); intrauterine devices (IUDs); condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.), hysterectomy or menopause must be clinically documented
Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study
RECIPIENT: Sexually active individuals capable of becoming pregnant who are unable or unwilling to use effective form(s) of contraception during time enrolled on study and for 1 year post-transplant; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence; women should not breast feed during the interval from study entry to one year post-transplant; males on the protocol must use an effective form of contraception at study entry, and for one year post-transplant
MATCHED RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
HAPLOIDENTICAL RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
Women of childbearing potential must be non-pregnant and non-lactating and willing to exercise an effective form of birth control during radiation therapy (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods, etc.); hysterectomy or menopause must be clinically documented
ELIGIBILITY CRITERIA FOR REGISTRATION: women of child-bearing potential must agree to use an effective method of birth control on trial; an effective method of birth control includes surgical sterilization of woman or her partner, abstinence, or two barrier methods (e.g. condom plus diaphragm); or hormonal methods of birth control (oral contraceptives or intrauterine device)
Sexually active individuals capable of becoming pregnant who are unable or unwilling to use effective form(s) of contraception during time enrolled on study and for 1 year post-transplant; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence; males on the protocol must use an effective form of contraception at study entry, and for one year post-transplant
MATCHED RELATED DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
HAPLOIDENTICAL DONOR: Donors must not be pregnant; pregnancy is an absolute contraindication under this protocol; donors of childbearing potential must use an effective method of contraception; effective forms of contraception include one or more of the following: intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, barrier methods, (condom, diaphragm, or cervical cap), or abstinence
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device (IUD), condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, intrauterine device [IUD], condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Women of childbearing age must have documentation of a negative pregnancy test and agreed that they or their partner use an effective contraceptive method such as condom/diaphragm and spermicidal foam, non-stainless-steel intrauterine device, or prescription birth control pills
Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation; pregnant and breastfeeding women will not be eligible
Adequate contraception for women is defined as hormonal birth control or an intrauterine device (safe hormonal contraceptives include contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). In countries where two highly effective methods of contraception are required this will be an inclusion criterion.
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner’s vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. A man who is sexually active with a woman of childbearing potential must always use a latex or synthetic condom during the study and for 4 months after discontinuing daratumumab
Women of childbearing potential and men who are sexually active must practice reliable contraceptive measures started at least 4 weeks before study therapy and continued for at least 4 weeks following discontinuation therapy; females of childbearing potential must either completely abstain from heterosexual sexual contact or must use 2 methods of reliable contraception; reliable contraceptive methods include 1 highly effective method (intrauterine device, birth control pills, hormonal patches, injections, vaginal rings, or implants) and at least 1 additional method (condom, diaphragm, or cervical cap) every time they have sex with a male; males who are sexually active must be practicing complete abstinence or agree to a condom during sexual contact with a pregnant female or female of child bearing potential; men must agree to not donate sperm during and after the study
Willing to adhere to medically accepted form of birth control to prevent pregnancy (includes: complete abstention from intercourse, condoms, diaphragms, cervical cap, intra-uterine device, history of surgical sterility – tubal ligation or vasectomy in patient or partner, or oral contraceptive)
Male and female subjects of reproductive potential agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) and abstain from other methods of conception during the study and for 6 months following the study cell infusion or proof of sterility
Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy; however, female subjects who are post-menopausal (including those with premature menopause due to high-dose chemotherapy) are exempted from this requirement; effective methods of contraception include:\r\n* Any intrauterine device (IUD) with a documented failure rate of less than 1% per year\r\n* Hormonal (birth control pills, injections, or implants)\r\n* Vasectomized partner who is sterile prior subject enrollment and is sole sexual partner of the subject\r\n* Male subjects: latex condom during sexual contact with female of childbearing potential even if he has undergone a successful vasectomy
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenalidomide: for at least 28 days before starting lenalidomide; while participating in the study including interruptions in therapy; and for at least 28 days after discontinuation/stopping lenalidomide; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal (birth control pills, injections, or implants, tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 30 days following the last dose of study drug; effective methods of birth control include: \r\n* Birth control pills, shots or implants (placed under the skin by a health care provider) or patches (placed on the skin);\r\n* Intrauterine devices (IUDs); \r\n* Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Any of the following:\r\n* Pregnant women\r\n* Nursing women\r\n* Women of child-bearing potential must agree to use two forms of adequate contraception from time of initial consent, for the duration of study participation, and for >= 6 months after the last dose of study drug; medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD); contraceptive measures such as Plan B, sold for emergency use after unprotected sex, are not acceptable methods for routine use; postmenopausal woman must have been amenorrheic for at least 2 years to be considered of non-childbearing potential; sexually active men must use at least one form of adequate contraception from time of initial consent, for the duration of study participation, and for >= 6 months after the last dose of study drug
Sexually active subjects (men and women) and all subjects of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method for at least 28 days prior, throughout the avelumab treatment and for at least 60 days after avelumab treatment; highly effective methods are defined as: intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation and partner’s vasectomy; other effective methods are defined as: latex condom, diaphragm and cervical cap
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through 4 months following the last dose of study drug
Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills
All patients of childbearing potential must be willing to consent to using effective contraception, i.e., intrauterine device (IUD), birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends
Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy
Men must agree to use adequate contraception (abstinence, vasectomy, or female partner use of intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation) prior to study entry and for up to one month after the last vaccination
Patients with female partners of childbearing potential must use at least one form of Investigator-approved contraception while on-study and for 30 days after their last administration of study investigational therapy. Acceptable birth control options include: a) surgical sterilization (subject and/or subject's partner), b) approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot), c) barrier methods (such as a condom or diaphragm) used with a spermicide, and d) an intrauterine device (IUD).
Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence.
Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence; contraception must be used during the study
FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: \r\n* For at least 28 days before starting lenalidomide\r\n* While participating in the study; and \r\n* For at least 28 days after discontinuation from the study; the 2 methods of reliable contraception must include a highly effective method (ie, intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and an additional effective (barrier) method (ie, latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed
REGISTRATION INCLUSION CRITERIA: If a woman of childbearing potential, patient must use two forms of effective contraception for a minimum of 6 months following trastuzumab; effective methods of birth control include use of established oral, injected, or implanted hormonal methods of birth control, intrauterine device (IUD), intrauterine system (IUS), and condoms
Women of childbearing potential must have a negative pregnancy test at time of screening and baseline visits and agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap)
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
Patients of childbearing or child fathering potential must be willing to use an acceptable method of birth control prior to study entry and for the duration of the study; acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence
Women of child bearing years must have a negative pregnancy test (serum or urine) within 1 week of study entry; men and women of reproductive potential must agree to use an effective contraceptive method including one of the following: surgical sterilization (tubal ligation for women or vasectomy for men); approved hormonal contraceptives (such as birth control pills, Depo-Provera or Lupron Depro); barrier methods (such as condom or diaphragm) used with a spermicide cream or an intrauterine device (IUD)
Women of childbearing potential are requested to use acceptable methods of birth control for the duration of the study and until persistence of the study drug is no longer detected in the patient. This may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception. It is recommended that a combination of two methods be used. Patients must have normal organ and marrow function as defined below:
Female patients of childbearing potential are not eligible unless they commit to complete abstinence or have been on 2 methods of birth control, including 1 highly effective method and 1 additional method at the same time (unless committing to complete abstinence of heterosexual intercourse) at least 28 days (4 weeks) prior to study enrollment; sexually active females must also agree to remain on 2 methods of birth control, during treatment (including during dose interruptions), and continuing for at least 28 days after the completion of protocol therapy; examples of methods of contraception are as follows:\r\n* Highly effective methods (must use at least 1):\r\n** Intrauterine device (IUD)\r\n** Hormonal (prescription birth control pills, injections, implants)\r\n** Tubal ligation\r\n** Partner’s vasectomy\r\n* Additional effective methods:\r\n** Male condom\r\n** Diaphragm\r\n** Cervical cap\r\nThe two methods of birth control requirement applies to all sexually active females unless they have undergone a hysterectomy or bilateral oophorectomy
Women of child-bearing potential eligible as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of the vaccination period; sexually active males must agree to use barrier contraceptive for the duration of the vaccination period
If a female of childbearing potential (FCBP), patient must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study; the two methods of reliable contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed\r\n* A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
Male subjects with partners of child-bearing potential, even if surgically sterilized (ie, status postvasectomy) must agree to abstain from sexual activity or to use 2 medically approved contraceptive measures / regimens from the time of signing the informed consent form through 3 months after the treatment period\r\n* Effective birth control includes: (a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method; or (b) 2 barrier methods; effective barrier methods are male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); for subjects using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known
Men or women of childbearing potential (WOCBP) who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
For female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control measures, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or [for male partner] condom) throughout the course of the study and for at least 90 days after the last administration of BAX69. Other acceptable contraceptive measures include birth control pills/patches or intrauterine devices
For male subjects, the subject must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and [for the female partner] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of BAX69
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with ipilimumab or dabrafenib; patients should agree to use an appropriate method of birth control while on study; examples of adequate forms of birth control for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator
Sexually active women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment
For patients of childbearing potential, agreement to use two effective forms of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study and for 30 days after the last LY3023414 dose
Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment
Females of childbearing potential must be willing to abstain from heterosexual activity or to use two effective methods of contraception from the time of informed consent until 4 months after the last dose of mirvetuximab soravtansine\r\n* Medically acceptable contraceptives include:\r\n** Surgical sterilization (such as a tubal ligation or hysterectomy)\r\n** Approved hormonal contraceptives (such as birth control pills, patches, implants or injections)\r\n** Barrier methods (such as a condom or diaphragm) used with a spermicide\r\n** An intrauterine device (IUD)\r\n* Contraceptive measures such as Plan B are not acceptable
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device, abstinence or other methods prescribed by a licensed healthcare provider) from the time of consent through 70 days following the last dose of study drug
Surgically or biologically sterile or willing to practice acceptable birth control, as follows:\r\n* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of day 1 of study treatment; women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period; acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence\r\n* Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period; acceptable methods of birth control include: barriers (condoms), oral contraceptive, IUD, transdermal/implanted or injected contraceptives, and abstinence
If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through 3 months following the last dose of study drug
Women of childbearing potential and male participants must agree to use a medically effective means of birth control, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills, throughout their participation in the treatment phase of the study
Men with partners of childbearing potential and women of childbearing potential who are not willing to use adequate contraception from study entry through one year following last treatment dose. (Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is the sole partner for a female subject. The double barrier method can be used in regions where considered acceptable and adequate, defined as condom or occlusive cap plus spermicidal agent).
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with nab-paclitaxel through 28 days after the last dose; men should be advised to not father a child while receiving treatment with nab-paclitaxel; appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator
Pregnant or lactating; patients of childbearing potential must use an effective method of contraception from the time of study entry to at least one year post-transplant; effective methods include intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation/hysterectomy, partner’s vasectomy, or barrier methods (condom, diaphragm, or cervical cap); males on the protocol, and their partners of child-bearing potential, must also use an effective form of contraception at study entry and for one year post-transplant; women should not breastfeed during the interval from study entry to one year post-transplant
Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel; appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator; male with partners of child bearing potential must practice reliable method of contraception (condoms) approved by the investigator; the patient must agree to continue use of birth control for at least 3 months after receiving last dose of study drugs
Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.
Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment and for 2 months after the last dose of chemotherapy; sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the last dose of chemotherapy
Males and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence
Females of child-bearing potential, who are not using adequate contraceptive measures (including condoms, birth control pills, intrauterine devices, contraceptive implants, or other United States [US] Food and Drug Administration [FDA]-approved contraceptives)
Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills; a negative pregnancy test must be obtained prior to study enrollment or waiver signed
Premenopausal women taking non hormonal intra-uterine device (IUD) birth control method will be eligible, if they have been on the same IUD for at least 3 months prior to enrollment and plan to continue using the same method throughout the study
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections, (2) barrier methods (such as condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\the pill\), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study treatment, and for a minimum of 6 months following trastuzumab and/or pertuzumab administration
Currently using two forms of effective birth control (one of which is a barrier method) for the duration of the study for both males and females of childbearing potential. Effective methods of birth control include hormonal contraception (i.e., birth control pills, injected hormones, vaginal ring), intrauterine device, or barrier methods with spermicide (i.e., diaphragm with spermicide, condom with spermicide), or
Negative serum beta-human chorionic gonadotropin (B-HCG) within 1 week of the study imaging with documentation of use of appropriate contraceptive measures (examples include abstinence, intrauterine device (IUD), hormonal methods (oral birth control pills, injections, implants), tubal ligation, and partner's successful vasectomy) after the B-HCG for females of childbearing potential
Women of childbearing potential and male participants must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills
Male and female participants with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after discontinuation of study treatment.