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

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 in

Trial Details

NCT ID

NCT07624513

Phase

PHASE3

Sponsor

Dana-Farber Cancer Institute

Status

RECRUITING

Cancer Type

Multiple Myeloma

Interventions

Isatuximab
Iberdomide
Bortezomib (B)
Dexamethasone
Melphalan
Linvoseltamab

Locations (sample)

Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

N- NDMM based on IMWG criteria with clonal bone marrow plasma cells ≥10% or biopsy proven bony or extramedullary disease/plasmacytoma (EMD) with an…
\- Age 18 - 75 years. (Patients aged 71-75 years who are deemed transplant-eligible by investigator may be enrolled after discussion with and appro…
\- 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 H…
\- Bone marrow analysis with cytogenetic risk status established by fluorescence in situ hybridization (FISH) and NGS with TP53 by PlasmaSEQ at scr…

For full eligibility, visit ClinicalTrials.gov.

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