NCT06918002

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

A Phase 3, Open-label, Controlled, Randomized Study of Newly Diagnosed Multiple Myeloma Treatment, Designed to Evaluate the Efficacy and Safety of the Elranatamab-lenalidomide Combination as a Replacement for Chemotherapy Followed by Autologous Stem Cell Transplant in the Consolidation Phase, and to Compare Elranatamab With Standard of Care in the Maintenance Phase

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 824 (estimated)
• Sponsor: Intergroupe Francophone du Myelome · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma, Newly Diagnosed

Interventions

Type	Name	Description
DRUG	Elranatamab	Elranatamab is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms
DRUG	Lenalidomide (Revlimid®)	In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), in monotherapy (Arm C)
DRUG	Daratumumab SC (Darzalex)	Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A
PROCEDURE	Autologous Stem Cell Transplantation	ASCT is performed in consolidation for Arm A patients after induction therapy with D-VRD
DRUG	Bortezomib (Velcade®)	Bortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A
DRUG	Dexamethasone	Dexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A

Timeline

• Start date: 2025-07-09
• Primary completion: 2036-05-01
• Completion: 2036-05-01
• First posted: 2025-04-09
• Last updated: 2026-04-02

Locations

64 sites across 1 country: France

Regulatory

• FDA-regulated drug study