Dana-Farber Cancer Institute
The purpose of the study is to determine the best treatment approach based on the risk profile of the cancer cells and on how the disease responds to treatment. This is a randomized research study evaluating treatment for transplant-eligible participants with newly diagnosed multiple myeloma (NDMM). Induction therapy in this study includes the drugs isatuximab, iberdomide, bortezomib, and dexamethasone. After induction therapy, participants will receive consolidation and maintenance therapy that is adapted based on their risk profile and response to treatment. The research study procedures include: screening for eligibility, study visits, blood and bone marrow tests, disease assessments, treatment with study drugs, and follow-up visits. It is expected that about 720 participants will take part in this study.
This is a Phase III, open-label, multicenter randomized research study designed to evaluate different treatment strategies for people with multiple myeloma. The study will look at how often participants achieve MRD (measurable residual disease)-negative status after maintenance therapy, compare different consolidation approaches, and assess long-term outcomes. Participants who are eligible will be assigned to study groups based on their cytogenetic risk and how their disease responds to induction therapy. All participants will first receive induction treatment with isatuximab, iberdomide, bor…
Inclusion Criteria: * N- NDMM based on IMWG criteria with clonal bone marrow plasma cells ≥10% or biopsy proven bony or extramedullary disease/plasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024) (See Appendix E) * \- Age 18 - 75 years. (Patients aged 71-75 years who are deemed transplant-eligible by investigator may be enrolled after discussion with and approval from the Sponsor - Investigator) * \- Eligible for HDM-ASCT, at time of registration per investigator's assessment, and willing to defer HDM-ASCT if in Cohort 1 or be randomized to HDM-ASC…
Supplied by Sanofi-Aventis (Sanofi); used in induction and maintenance/consolidation strategies in this protocol; administered subcutaneously (SC) in the maintenance tables provided; not administered in Arm C.
Supplied by Bristol Myers Squibb/Celgene (BMS); used across induction and maintenance phases; administered orally.
Commercial supply; used in induction and Arm G maintenance; administered subcutaneously in Arm G on Days 1 and 15 of each 28-day cycle.
Commercial supply; used in induction; may be administered intravenously or orally at investigator discretion; excluded from Arm G.
Commercial supply; used as conditioning therapy for Arm E before PBSC infusion/ASCT; administered intravenously.
Supplied by Regeneron; used in Arm F consolidation for 8 cycles before maintenance therapy.
Device: On Body Delivery System (OBDS) - Sanofi-Aventis device used with isatuximab administration; abdominal/periumbilical single-site application with post-dose needle retraction and lock-out.