--- a
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+STEP I: Patient enrolling to this study must agree to register to the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+STEP II: Patient enrolling to this study must agree to register to the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
+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
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program
+Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to start of treatment. Participants must agree to ongoing pregnancy testing. All patients must be willing to comply with all requirements of the USA pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program or the pomalidomide Pregnancy Prevention Plan (PPP).
+All study participants in the United States (US) must be consented to and registered into the mandatory revlimid (lenalidomide) REMS program and be willing and able to comply with the requirements of revlimid REMS
+FCPB must have a negative urine or serum pregnancy test within 7 days prior to registration, and be willing to adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS®) program\r\n* NOTE: should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
+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
+All study participants must be registered into the mandatory POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS)(TM) program, and be willing and able to comply with the requirements of the POMALYST REMS(TM) program; for subjects enrolled outside of the United States, Pomalidomide counseling but be completed by a designated counselor
+Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the REVLIMID Risk Evaluation and Mitigation Strategy (REMS) program
+Willing to be registered into the mandatory REVLIMID REMS program, and willing and able to comply with the requirements of the REVLIMID REMS program
+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
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be registered into the mandatory pomalidomide (POMALYST) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program
+All study participants must be registered into the mandatory Revlimid (lenalidomide) Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of the REMS program
+All study participants must be registered in the Revlimid (lenalidomide) Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be registered into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of REMS
+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 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 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 28 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: 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).
+All study participants must be registered into the mandatory Revlimid REMS program and be willing to comply with its requirements; per standard Revlimid REMS program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS program
+All subjects must agree to comply with and be enrolled in Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of Revlimid REMS; NOTE: females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMSTM program
+Willing to follow the requirements of the Pomalyst REMS program
+All study participants must be registered into the mandatory pomalidomide (POMALYST) Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the POMALYST REMS program
+Females of reproductive potential must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS program
+Agree to be registered in and comply with all requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program (Cohorts B, C, E)
+Agree to be registered in and comply with all requirements of the Pomalyst REMS program (Cohort F)
+Persons able to become pregnant must be willing to adhere to the scheduled pregnancy testing as required in the REVLIMID Risk Evaluation and Mitigation Strategy (REMS) program
+Willing to be registered into the mandatory REVLIMID REMS program, and willing and able to comply with the requirements of the REVLIMID REMS program
+Willing to follow the requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+Registered into Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+All study participants must be registered into the mandatory Revlimid risk evaluation and mitigation strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants in the US must be consented to and registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program and be willing and able to comply with the requirements of Revlimid REMS
+Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only \r\n* NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+Willing to adhere to the guidelines of the Revlimid REMS (formerly known as RevAssist) program\r\n* NOTE: The counseling must be documented
+All study participants must agree to be registered into the mandatory REVLIMID REMS program, and be willing and able to comply with the requirements of the REVLIMID REMS program
+All study participants must be willing to register with the mandatory RevAssist program and be willing to comply with its requirements
+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 REMS program
+All study participants must agree to be registered into the mandatory POMALYST Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+Willing and able to register into and comply with the mandatory requirements of Celgene’s REVLIMID REMS program
+Females of reproductive potential are willing and able to adhere to the scheduled pregnancy testing as required by Celgene’s REVLIMID REMS program
+All study participants must be registered into the mandatory Revlimid REMS program and be willing to comply with its requirements; per standard Revlimid REMS program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS), and be willing and able to comply with the requirements of the Revlimid REMS
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS
+All study participants be willing and able to comply with the requirements of the Risk Evaluation and Mitigation Strategies (REMS) program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+Patient enrolling to this study must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (REMS [TM]) program, and be willing and able to comply with the requirements of (REVLIMID REMS [TM])
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS program
+All study participants must be willing to be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program after completion of induction chemoimmunotherapy and prior to maintenance therapy, and be willing and able to comply with the requirements of the Revlimid REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+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
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must agree to be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program
+Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS program
+All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of Revlimid REMS
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+Subject is registered into the mandatory RevAssist® program, and is willing and able to comply with the requirements of RevAssist® program.
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+Registered into mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
+Women of childbearing potential: adhere to scheduled pregnancy testing as required in the Revlimid REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
+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
+Lactating or pregnant patients or patients of reproductive potential not willing to use effective methods of contraception and adhere to the Revlimid REMS program
+All patients must be registered in and must comply with all requirements of the Revlimid Rems program.
+All study participants must be registered into the mandatory pomalidomide (POMALYST) REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program
+All study participants must be registered into the mandatory POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program
+Willing and able to comply with the requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+Females of childbearing potential must be willing to adhere to the scheduled pregnancy testing as required by the Revlimid REMS program
+Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS (TM) program
+Willing to be registered into the mandatory POMALYST REMS (TM) program, and willing and able to comply with the requirements of the POMALYST REMS (TM) program
+If assigned to receive lenalidomide and a female of reproductive potential, must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+If assigned to receive lenalidomide, patient must be registered into the mandatory Revlimid REMS program and be willing and able to comply with the requirements of the REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program and be willing to comply with its requirements; per standard Revlimid REMS program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS program
+Patients must be registered to the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)™ program and must be willing and able to comply with the requirements of the Revlimid REMS™ program
+All study participants must be registered into the mandatory Revlimid (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS
+All study participants must be registered into the mandatory Revlimid REMS ™ Revlimid REMS™ program, and be willing and able to comply with the requirements of Revlimid REMS™
+All study participants must be registered into the mandatory Revlimid REMS program, and be\r\nwilling and able to comply with the requirements of the REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)TM program, and be willing and able to comply with the requirements of the Revlimid REMSTM program; females of childbearing potential must adhere to the scheduled pregnancy testing and contraception as required in the Revlimid REMSTM program; a female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
+Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of Rems
+All study participants must be registered into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of REMS
+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
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+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
+Females of reproductive potential who will receive lenalidomide must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program
+All study participants who will receive lenalidomide must be registered into the mandatory Revlimid REMS(TM) program, and be willing and able to comply with the requirements of the REMS(TM) program
+All study participants enrolled in the lenalidomide containing cohort (cohort 2) must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the REMS program
+All study participants must be registered into the mandatory Revlimid (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+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
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+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
+All patients enrolled into this trial, must be registered in and must comply with all requirements of the POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS) program
+Must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirement of RevAssist®
+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
+All study participants must be registered into the mandatory electronic Risk Evaluation and Mitigation Strategies (eREMS) program, and be willing and able to comply with the requirements of REMS
+All study participants must be registered into the mandatory POMALYST (pomalidomide) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program
+All study participants enrolled in the United States must be registered into the mandatory REVLIMID Rems program and be willing and able to comply with the requirements of REVLIMID Rems
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory POMALYST Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program
+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
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+Subjects must agree to follow all Guidelines from REVLIMID REMS Program or POMALYST REMS
+Must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the study Manual (all other participants who were not using commercial supplies)
+All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of Revlimid REMS program
+All study participants must be registered into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of REMS
+All subjects must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. All counseling will be done through RevAssist®.
+Patient must be registered into the mandatory Revlimid REMS program and be willing and able to comply with the requirements of Revlimid REMS
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory electronic Risk Evaluation and Mitigation Strategies (eREMS) program, and be willing and able to comply with the requirements of REMS
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the Revlimid REMS program
+All study participants must be registered into the mandatory Revlimid risk evaluation and mitigation strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+All study participants must be registered into the mandatory Revlimid assistance (RevAssist) program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+Females of childbearing potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be willing to be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)® program, and be willing and able to comply with the requirements of the REMS® program; NOTE: Actual registration in the Revlimid REMS® program may occur after the patient is randomized since this requirement only applies to patients randomized to Arm A
+Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; NOTE: This requirement only applies to patients randomized to Arm A
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)® program, and be willing and able to comply with the requirements of Revlimid REMS®
+All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®; drug dispensing must come from the Celgene approved pharmacy, Biologics (Clinical Trials Services)
+Patients must be informed of the Celgene Risk Management Program and mandatory registration as well as be willing and able to comply with its requirements
+All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®
+In order to obtain lenalidomide, patients must be registered into the mandatory RevlimidREMS program during the maintenance phase of therapy, and be willing and able to comply with the requirements of RevlimidREMS
+All study participants must be registered into the mandatory lenalidomide Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of the REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the lenalidomide REMS program
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
+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 REMS® program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS)® program
+Willing to be registered into the mandatory Revlimid REMS® program, and willing and able to comply with the requirements of the REMS® program
+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 REMs program; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+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