[c09aa8]: / clusters / final9knumclusters / clust_1955.txt

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RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): \r\n* Women of childbearing potential:\r\n** Must have a negative serum or urine pregnancy test within 72 hours prior to re-registration\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 28 days about pregnancy precautions and risks of fetal exposure
All pts must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
Be counseled about pregnancy precautions and risks of fetal exposure and agree to requirements of the Pregnancy Prevention and Risk Management Plan (PPRMP)
Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program material; this is defined as either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of contraception (one highly effective method and one additional effective method (AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last doses of brentuximab vedotin and lenalidomide; women of childbearing potential must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
All participants who are prescribed lenalidomide or pomalidomide must be counseled at a minimum of every 21-28 days about pregnancy precautions and risks of fetal exposure (Cohorts B, C, E, F)
Men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Male subjects must agree to use a latex or synthetic condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 60 days after the last dose of POM or TEW-7197; male subjects must not donate sperm; all patients must be counseled at a minimum of every 28 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
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 28 days about pregnancy precautions and risks of fetal exposure
Women of childbearing potential must follow pregnancy testing requirements; this is defined as either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last doses of brentuximab vedotin and lenalidomide; women of childbearing potential must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Female who is able to become pregnant must have a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide; female who is able to become pregnant must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective and one additional effective method at the same time; female who is able to become pregnant must agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with female who is able to become pregnant even if they had vasectomy for the duration of study participation, and 28 days after completion of pomalidomide administration; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure while taking pomalidomide; 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
Agree to adhere to methods of contraception and other fertility control measures as prescribed by the protocol\r\n* Women of child-bearing potential and men must agree to use effective forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; 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\r\n* Female subjects\r\n** Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 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 28 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 28 days about pregnancy precautions and risks of fetal exposure through the POMALYST Risk Evaluation and Mitigation Strategy (REMS)™ program\r\n* Male subjects\r\n** Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation of study drug even if he has undergone a successful vasectomy\r\n** Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure\r\n** Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation of study drug\r\n** Must agree that if a pregnancy or a positive pregnancy test does occur in a study subject or the partner of a male study subject during study participation, study drug must be immediately discontinued\r\n* Patients must agree to not share study drug with anyone during participation in the study
Female patients of childbearing potential (including those who commit to complete abstinence) are not eligible unless they agree to ongoing pregnancy testing and counseling every 28 days about pregnancy precautions and risks of fetal exposure
All subjects must be counseled about pregnancy precautions and risks of fetal exposure.
Be counseled about pregnancy precautions and risks of fetal exposure
Be counseled about pregnancy precautions and risks of fetal exposure. ARM B ONLY:
Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.
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 28 days about pregnancy precautions and risks of fetal exposure