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

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 t

Trial Details

NCT ID
NCT06918002
Phase
PHASE3
Sponsor
Intergroupe Francophone du Myelome
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Elranatamab
  • Lenalidomide (Revlimid®)
  • Daratumumab SC (Darzalex)
  • Autologous Stem Cell Transplantation
  • Bortezomib (Velcade®)
  • Dexamethasone
Locations (sample)
  • Amiens, France|49.9,2.3
  • Angers, France|47.47156,-0.55202
  • Annecy, France|45.90878,6.12565
  • Argenteuil, France|48.94788,2.24744
  • Avignon, France|43.94834,4.80892

Key Eligibility Criteria

  • Male or female subjects, aged over 18.
  • Patients have provided voluntary written informed consent before performing any study-related procedure.
  • Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT).
  • Patients with documented symptomatic NDMM according to CRAB and/or SLIM criteria, with measurable disease as defined by:

For full eligibility, visit ClinicalTrials.gov.

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