Comparing Three Treatment Approaches for Newly Diagnosed Multiple Myeloma Patients Eligible for Stem Cell Transplantation Extended VRD Plus Early Rescue, Isatuximab with VRD, or Isatuximab with Iberdomide and VRD

What this Trial Is About

The trial investigates treatment options for adults with newly diagnosed multiple myeloma who are eligible for stem cell transplantation. It is a Phase III, open-label, randomized study comparing three treatment approaches to evaluate their effectiveness in achieving minimal residual disease negativity using next-generation flow cytometry. The study aims to compare an extended VRD regimen plus early rescue intervention with two Isatuximab-containing regimens. Participants are assigned to one of three groups Arm A receives Isatuximab combined with VRD followed by autologous stem cell transplant ASCT, then consolidation and continuous treatment with Lenalidomide and monthly Isatuximab Arm B receives an extended VRD regimen with ASCT plus early rescue intervention involving Isatuximab-Iberdomide-Dexamethasone, followed by consolidation and continuous treatment with adjusted VRD cycles Arm C is treated with Isatuximab, Iberdomide, VRD, and ASCT, followed by consolidation and continuous treatment with Iberdomide and monthly Isatuximab. Each treatment phase includes induction, ASCT, consolidation, and continuous therapy lasting approximately 24 months or longer. Throughout the study, participants undergo multiple cycles of treatment with frequent dosing schedules, including intravenous infusions and oral medications. Researchers assess the primary outcome by measuring the proportion of participants who are MRD-negative after 18 cycles plus ASCT, approximately 24 months. Safety and progression-free survival are monitored over about 78 months. The study also involves bone marrow analyses, adherence tracking, and reviews of therapeutic programs up to 36 months. Participants are followed closely for treatment response and adverse events during and after therapy.

NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide