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

• Status: RECRUITING
• Trial end date: 2036-05-01

Summary

This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT.

824 patients will be enrolled in this study from approximately 70 study sites.

The 2 parts in the Treatment Phase are described below.

Part 1: Induction/ASCT/Consolidation Phase (1:1 Randomization)

After the screening period, patients will be randomly allocated (1:1) to either:

• Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy
• Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.

Part 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy.

• Arm C (standard of care arm): lenalidomide
• Arm D (experimental arm): elranatamab

• Phase: PHASE3

Details

• Lead Sponsor: Intergroupe Francophone du Myelome
• Collaborator: Pfizer
• Treatments: Bortezomib; daratumumab; Dexamethasone; Lenalidomide