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

NCT06918002 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 824

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Intergroupe Francophone du Myelome

    lead NETWORK

Principal Investigators

  • Chanaz LOUNI · The Institute for Functional Medicine

  • Aurore PERROT, Prof · IUCT Toulouse France

  • Cyrille TOUZEAU, Prof · CHU Nantes France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2036-05-31
Completion
2036-05-31
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918002 on ClinicalTrials.gov