[c09aa8]: / clusters / 9knumclustersv2 / clust_1980.txt

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STEP I: Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide throughout the entire duration of study treatment, and for days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure; female subjects must agree to use contraception or abstinence for days after last dose of carfilzomib\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months
STEP II: Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide throughout the entire duration of study treatment, and for days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months
Not pregnant and not nursing\r\n* Females of childbearing potential (FCBP), defined as a female who ) has achieved menarche (first menstrual cycle) at some point, or ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries), or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months):\r\n** Must have a negative serum or urine pregnancy test with a sensitivity of a least mIU/mL within - days prior to registration and again within hours of starting lenalidomide\r\n** Must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide\r\n** Must agree to ongoing pregnancy testing\r\n* Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to starting cycle of lenalidomide; further, they must either commit to complete 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 or post ovulation methods] and withdrawal are not acceptable methods of contraception) from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide; while taking lenalidomide, during dose interruptions, and for at least days after the last dose of lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a female who: ) has achieve menarche at some point; ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months); all patients must be counseled by a trained counselor every days about pregnancy precautions and risks of fetal exposure; NOTE: patients not randomized to receive lenalidomide will not be required to undergo serial pregnancy testing or lenalidomide counseling after registration
A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)\r\n* Women of childbearing potential:\r\n** Must have a negative serum or urine pregnancy test with a sensitivity of at least mlU/ml no more than days prior to registration and must agree to repeat this test within hours of starting pomalidomide\r\n** Must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, before starting pomalidomide\r\n** Must agree to ongoing pregnancy testing\r\n** Must agree to not become pregnant or breast feed a child during treatment on this protocol\r\n* Men must practice complete abstinence or agree to use a condom during sexual contact with a female of childbearing potential, even if they have had a successful vasectomy\r\n* Note: All participants must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure
Females of childbearing potential (FCBP)\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months\r\n* Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test with a sensitivity of at least mIU/ml, within - days of study start (during screening)\r\n* ARM FCBP must also have a negative pregnancy test within hours prior to prescribing lenalidomide in cycle \r\n* In addition, ARM FCBP must have prescriptions filled within days (as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least days before she starts taking lenalidomide\r\n* FCBP must also agree to ongoing pregnancy testing. Pregnancy testing is not required for post-menopausal or surgically sterilized women\r\n* Females must agree to avoid pregnancy during the study and must agree to use a medically acceptable method of birth control as determined by the study doctor while participating in
All patients must agree to use effective contraception while on study, and all patients must agree to undergo counseling sessions every days about pregnancy precautions and risks of fetal exposure\r\n* Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide, during lenalidomide therapy, during dose interruptions, and for at least days following discontinuation of lenalidomide therapy\r\n* Males receiving lenalidomide must agree to use a latex condom during any sexual contact with FCBPs even if they have undergone a successful vasectomy\r\n* NOTE: a FCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n** Has not undergone a hysterectomy or bilateral oophorectomy\r\n** Has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)\r\n* FCBP should be referred to a qualified provider of contraceptive methods, if needed
Female patients who are postmenopausal for at least year before the screening visit or are surgically sterile; females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; female patients must agree to practice two effective methods of birth control from the time of signing the informed consent form though days after the last dose of study drug\r\n* A female of childbearing potential is a sexually mature female who:\r\n** Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or\r\n** Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours of starting lenalidomide and ixazomib and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide through days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through days after the last dose of study drug; in the event that the male patients choose to agree to practice true abstinence, this must follow the timelines detailed above; all patients assigned to the lenalidomide treatment group must be registered in and must comply with all requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months
Females of childbearing potential (FCBP)* must have a negative serum pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours prior to prescribing pomalidomide for cycle (prescriptions must be filled within days as required by RevAssist [lenalidomide REMS program]), and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method; AT THE SAME TIME, at least days before she starts taking pomalidomide FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; patient must follow pregnancy testing requirements as outlined in the POMALYST REMS program\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Women of childbearing potential and sexually active males must agree to use methods of an accepted and effective method of contraception and counseled on the potential teratogenic effects of lenalidomide; effective contraception must be used by patients for at least weeks before beginning lenalidomide therapy, during lenalidomide therapy, during dose interruptions and for weeks following discontinuation of lenalidomide therapy; reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or because the patient has been postmenopausal naturally for at least consecutive months; two reliable forms of contraception must be used simultaneously unless continuous abstinence from heterosexual sexual contact is the chosen method; females of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least consecutive months (i.e., who have had menses at some time in the preceding consecutive months) are considered to be females of childbearing potential; it is not known whether CC- (lenalidomide) is present in the semen of patients receiving the drug; therefore, males receiving CC- (lenalidomide) must always use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy
Women of childbearing potential and men must agree to use adequate contraception; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure; should 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; in regards to carfilzomib, FCBP must agree to use at least one method of effective contraception for at least days after the last dose of carfilzomib and males must agree to use contraception and not to donate sperm for at least days after the last dose of carfilzomib\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS program. program, and be willing and able to comply with the requirements of the Revlimid REMS program.\r\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by the Revlimid REMS program) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.\r\n** A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months).
Lenalidomide-related inclusion criteria:\r\n* Able to take aspirin ( mg or mg) daily, warfarin, low molecular weight heparin, or equivalent anticoagulation as prophylactic medication\r\n* All study participants must be registered into the mandatory REVLIMID Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of REMS\r\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours prior to starting REVLIMID and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking REVLIMID; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* For women, effective contraception is required to continue for >= months after the last dose of obinutuzumab, or days after the last dose of lenalidomide, whichever is later; for men, effective contraception is required to continue for months after the last dose of obinutuzumab treatment, or days after the last dose of lenalidomide, whichever is later\r\n* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the REVLIMID REMS program\r\n** A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting lenalidomide and LDE and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide and LDE; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least weeks before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL - days prior to and again within hours before starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test prior to initiation of the study treatment with TEW- /POM; the test must have a sensitivity of at least mIU/mL; study participants who are FCBP must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least days before she starts taking POM through days after the last dose of POM and days after the last dose of TEW-; FCBP must also agree to ongoing pregnancy testing during the entire duration of treatment; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure; all patients enrolled into this trial, must agree to be registered in and must comply with all requirements of the POM REMS program\r\n* A female of childbearing potential (FCBP) is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
This protocol defines a female of childbearing potential (FCCBP) as a sexually mature female (at least Tanner ) who: ) has not undergone a hysterectomy or bilateral oophorectomy or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)\r\n* Criteria for female children of childbearing potential (FCCBP)\r\n** This protocol defines FCCBP as females who have:\r\n*** Achieved menarche and/or breast development in Tanner stage or greater\r\n*** Has not undergone a hysterectomy or bilateral oophorectomy; \r\n*** Note: amenorrhea following cancer therapy does not rule out childbearing potential\r\n* Criteria for female children not of childbearing potential (FCBCBP)\r\n** This protocol defines FCNCBP as females:\r\n*** Who have not yet experienced menarche or breast development in Tanner stage \r\n*** Who have undergone a hysterectomy or bilateral oophorectomy\r\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to starting course of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature female (Tanner stage ) who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months); all patients must be counseled by a trained counselor every days about pregnancy precautions and risks of fetal exposure\r\n* Male subjects\r\n** Appropriate male subjects (i.e. those who have reached puberty and are sexually active) will be counseled regarding birth control methods; they must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least days following discontinuation from the study even if he has undergone a successful vasectomy\r\n** Appropriate male patients will be given a reproductive risks handout and counseled by a provider; for sexually active patients, the counseling session, consent and counseling checklist will be documented monthly
Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting cycle of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months); all patients must be counseled by a trained counselor every days about pregnancy precautions and risks of fetal exposure
All subjects and/or parents/guardians must have an understanding that lenalidomide could have a potential teratogenic risk. Female Children of Childbearing Potential, defined as females who have achieved menarche and/or breast development in Tanner Stage or greater and have not undergone a hysterectomy or bilateral oophorectomy and FCBP defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least consecutive months (ie, has had menses at any time in the preceding consecutive months) must meet the following conditions below (Note: Amenorrhea following cancer therapy does not rule out childbearing potential): - Medically supervised serum pregnancy tests with a sensitivity of at least mIU/mL must be conducted in FCCBP/FCBP, including those who commit to complete abstinence*. FCCBP/FCBP must have two pregnancy tests (with a minimum sensitivity of mIU/mL) prior to starting treatment with lenalidomide. The first pregnancy test must be performed within - days prior to the start of lenalidomide treatment and the second pregnancy test must be performed within hours prior to starting treatment with lenalidomide. NOTE: The pregnancy test to days prior to initiation of lenalidomide may be omitted, at the discretion of the investigator, for any FCCBP/FCBP who has high acuity disease requiring immediate treatment with lenalidomide. The pregnancy test within hours prior to the first dose of lenalidomide is required to be performed. The subject may not receive Investigational Product (IP) until the Investigator has verified that the results of these pregnancy tests performed on Cycle Day are negative. FCCBP/FCBP with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first days of study participation and then every days while on study, at study Treatment Discontinuation Visit, and at Day following IP discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first days and then every days while on study, at study Treatment Discontinuation Visit, and at Days and following IP discontinuation.
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to starting cycle of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months); all patients must be counseled by a trained counselor every days about pregnancy precautions and risks of fetal exposure
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to registration; (Note: that pregnancy testing is also required within hours prior to treatment on cycle , day ); furthermore, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for re-induction/consolidation (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing\r\n* A FCBP is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours of starting thalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least weeks before she starts taking thalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Female patients who are postmenopausal for at least year before the screening visit or are surgically sterile; females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid Risk Evaluation and Mitigation Strategy [REMS]) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; females of reproductive potential must agree to follow instructions for method(s) of contraception for the duration of treatment with any study drug(s) plus half-lives of study plus days (duration of ovulatory cycle) for a total of days after their last dose of lenalidomide (Revlimid); women must not breastfeed\r\n* Female patients who are of childbearing potential must use contraception for half-lives plus days after their last dose of nivolumab for a total of months\r\n* A female of childbearing potential is a sexually mature female who:\r\n** Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or\r\n** Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test at enrollment; FCBP must either commit to abstinence from heterosexual intercourse or commit to the use of acceptable methods of birth control; a FCBP is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least uL/mL to days prior to therapy and repeated again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS program) and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least days before she starts taking lenalidomide; females of child bearing potential (FCBP) must also agree to ongoing pregnancy testing; men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy; all study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the REMS program; a female of childbearing potential is a sexually mature female who:\r\n* Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries)\r\n* Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid Risk Evaluation and Mitigation Strategy [REMS]) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide\r\n* A female of childbearing potential is a sexually mature female who:\r\n** Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or\r\n** Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy; all patients must be counseled\r\nat a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mlU/mL to days prior to therapy and repeated again within hours of starting lenalidomide and must either commit to complete abstinence from heterosexual contact or begin TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method, AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy; all participants agree to enroll and comply with the RevAssist program for the prevention of pregnancy\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting cycle of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide and for days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; a FCBP is a female who: ) has achieved menarche at some point, ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months); all patients must be counseled by a trained counselor every days about pregnancy precautions and risks of fetal exposure
Females of childbearing potential (FCBP) must have a negative pregnancy test (sensitivity of at least mIU/mL) performed once before ibrutinib and a total of two negative tests before initiating lenalidomide; a FCBP is a sexually mature woman who: ) has achieved menarche at some point; ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months); the pre- ibrutinib pregnancy test will be initiated at enrollment; the first pre-lenalidomide test will be performed within - days of starting lenalidomide (cycle , day ), and the second pre- lenalidomide test (rd total test) will be within hours of the first dose of lenalidomide; the patient may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative; pregnancy tests (if applicable) are then to be conducted weekly during the first month, and monthly thereafter in women with a regular menstrual cycle, as well as at study discontinuation, and at day following study discontinuation; if menstrual cycles are irregular, pregnancy testing will be conducted weekly for the first month, and then every days while on the study, at study discontinuation, and at days and following study drug discontinuation; pregnancy testing and counseling are to be performed if a patient misses her period or if there is any abnormality in menstrual bleeding; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; male and female patients, must agree to use highly effective methods of birth control (e.g. condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for days after the last dose of study drug; all patients must be counseled by a trained counselor every days about pregnancy precautions and risks of fetal exposure
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST Risk Evaluation and Mitigation Strategy (REMS) program; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing pomalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure; all study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program; Females of childbearing potential (FCBP) must have a negative serum pregnancy test with a sensitivity of at least . IU/L within days and again within hours prior to receiving lenalidomide for cycle and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBPs must also agree to ongoing pregnancy testing and for days after receiving their last dose of lenalidomide\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has menses at any time in the preceding consecutive months
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature female who\r\n** Has not undergone a hysterectomy or bilateral oophorectomy; or\r\n** Has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to enrollment and again within hours of starting PF- and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable barrier methods of birth control (one of which is used by the partner) AT THE SAME TIME, at least days before she starts taking PF-, during receipt of PF-, and months after discontinuation of PF-; documentation of the second method is by patient report; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or a bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Patients must be willing to practice appropriate birth control methods during the study and for days after their participation in the treatment portion of the study is concluded; females of childbearing potential (FCBP*) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing cycle of lenalidomide (prescriptions must be filled within days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to enrollment and again within hours prior to starting cycle of sEphB-HSA; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME during receipt of sEphB-HSA, and weeks after discontinuation of sEphB-HSA; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least consecutive months (i.e., has had menses at any time during the preceding consecutive months)
Females of childbearing potential (FCBP)* must have a negative serum pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid Risk Evaluation and Mitigation Strategy [REMS]), and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all study participants must be registered into the Revlimid REMS program, and be willing and able to comply with the requirements of Revlimid REMS program\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months)
Females of childbearing potential: confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women; females with child bearing potential (FCBP) must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; (FCBP - A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months)
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL prior to receiving treatment with lenalidomide, and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy\r\n* Female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least consecutive months (i.e., has had menses at any time in the preceding consecutive months) minorities are included in the eligibility criteria