D2 - Isa-Iber-VD Induction, Followed by Risk & Response Adapted Consolidation & Maintenance, in Transplant-Eligible NDMM
Sponsor: Dana-Farber Cancer Institute • ClinicalTrials.gov ID: NCT07624513
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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.
Interventions
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Isatuximab
(Drug)
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.
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Iberdomide
(Drug)
Supplied by Bristol Myers Squibb/Celgene (BMS); used across induction and maintenance phases; administered orally.
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Bortezomib (B)
(Drug)
Commercial supply; used in induction and Arm G maintenance; administered subcutaneously in Arm G on Days 1 and 15 of each 28-day cycle.
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Dexamethasone
(Drug)
Commercial supply; used in induction; may be administered intravenously or orally at investigator discretion; excluded from Arm G.
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Melphalan
(Drug)
Commercial supply; used as conditioning therapy for Arm E before PBSC infusion/ASCT; administered intravenously.
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Linvoseltamab
(Drug)
Supplied by Regeneron; used in Arm F consolidation for 8 cycles before maintenance therapy.
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On Body Delivery System (OBDS)
(Device)
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.
Eligibility criteria
Conditions
Locations
- Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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