Phase 3 Study Comparing Elranatamab-Lenalidomide Therapy to Standard Chemotherapy and Stem Cell Transplant in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

What this Trial Is About

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients