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

Sponsor
Intergroupe Francophone du Myelome
Study ID
NCT06918002
Phase
PHASE3
Status
Recruiting
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Conditions

  • Multiple Myeloma, Newly Diagnosed

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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): daratumumab + lenalidomide approx 2 years. Subjects with a negative MRD (for at least 12 months) after 24 cycles of daratumumab-lenalidomide will discontinue daratumumab and continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first). Subjects who did not achieve MRD negativity for at least 12 months after 24 cycles of daratumumab-lenalidomide will continue to receive daratumumab-lenalidomide until: * MRD negativity for at least 12 months is reached. Subjects will then continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first). * Disease progression * Or study cut-off date (whichever occurs first). * Arm D (experimental arm): elranatamab. Approx 2 years. Subjects with a negative MRD (for at least 12 months) after receiving M22 administration of elranatamab will discontinue study treatment with elranatamab. Subjects who did not achieve MRD negativity for at least 12 months after M22 elranatamab administration will continue to receive elranatamab, every 24 weeks, until MRD negativity for at least 12 months is reached, disease progression, or study cut-off date (whichever occurs first).

Key Dates

Start date
Jul 9, 2025
Status verified
May 2026
Primary completion
May 31, 2036
Completion
May 31, 2036

Study Design

Enrollment
824 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: D-VRD induction, ASCT and D-VRD consolidation (arm A)
    Standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, and 2 cycles of D-VRd consolidation therapy
  • Experimental: D-VRD induction followed by elranatamab and lenalidomide consolidation (arm B)
    Standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.
  • Active Comparator: daratumumab + lenalidomide maintenance (Arm C)
    Daratumumab + Lenalidomide for two years (maintenance)
  • Experimental: elranatamab maintenance (Arm D)
    Elranatamab monotherapy for two years (maintenance)

Primary Outcome Measure

Part 1 (induction/consolidation) from Randomization 1 (R1): to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Minimal Residual Disease (MRD) negativity rate [ Time Frame: at end of consolidation, up to 36 months ]

Central Contacts

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