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D2 - Isa-Iber-VD Induction, Followed by Risk & Response Adapted Consolidation & Maintenance, in Transplant-Eligible NDMM

StatusNot Yet Recruiting
PhasePhase 3
Started2026-08-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v1
Start date2026-06-08→2026-08-24
Eligibility criteria-1 characters
[...] ansfusions required during the 14 days prior to registration) Total Bilirubin ≤ 2 X upper limit of normal (ULN) (except p [...]
Study description+252 characters
[...] a. The study will look at how often participants achieve MRD (measurable residual disease)-negative status after maintenance therapy, compare differen [...] n on the combination treatment. Participants with high-risk disease,cytogenetics orand those who areremain MRD-positive orafter havecompletion indeterminateof MRD results,induction will be randomized to receive either consolidation with high-dose melphalan followed by autologous stem cell transplant, or eight cycles of linvoseltamab consolidation, followed by maintenance therapyisatuximab and iberdomide until progression of disease. Participants [...] [...]
Study title-109 characters
Determination 2D2 - Isatuximab, Iberdomide, Bortezomib and DexamethasoneIsa-Iber-VD Induction, Followed by Risk- and& Response- Adapted Consolidation and& Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple MyelomaNDMM
2026-05-28
Original filing
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.
Trial Details
NCT Number NCT07624513
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Sanofi, Bristol-Myers Squibb, Celgene Corporation, Regeneron Pharmaceuticals
Conditions Multiple Myeloma
Enrollment 720 participants
Start Date 2026-08-24
Primary Completion 2033-10-01 (estimated)
Study Completion 2038-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-08