Beaumont Hospital | Cancer Clinical Trials and Research Unit
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This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.
Enrollment
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Inclusion criteria
Participants must have a diagnosis of MM according to Revised International Myeloma Working Group diagnostic criteria (Rajkumar 2014):
Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:
End organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
One or more of the following biomarkers of malignancy:
Patient has received no prior treatment with any systemic therapy for the treatment of multiple myeloma.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Age ≥ 18 years at the time of signing Informed Consent.
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Lenalidomide Pregnancy Prevention Risk Management Plan. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25mlU/mL 10 to14 days prior to therapy and repeated again within 24 hours prior to prescribing lenalidomide for induction Cycle 1 (prescriptions must be filled within 7 days as required by the Lenalidomide Pregnancy Prevention Risk Management Plan) 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 28 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 study participants must be registered into the mandatory Lenalidomide Pregnancy Prevention Risk Management Plan, and be willing and able to comply with the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.*A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).
All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrolment.
Subject has an ECOG performance status of < 2 or Karnofsky performance status of ≥ 60 (Appendix E).
Subject must be able to adhere to the study visit schedule and other protocol requirements.
Participants must also have measurable disease according to the Standard Diagnostic Criteria (Rajkumar 2009):
Exclusion criteria
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
Primary purpose
Allocation
Interventional model
Masking
43 participants in 1 patient group
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Central trial contact
Adelle McGourty
Data sourced from clinicaltrials.gov
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