Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of C
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: In
| Condition(s) | Multiple Myeloma, Newly Diagnosed |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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) Patien |
| Who can participate | Inclusion Criteria: 1. Male or female subjects, aged over 18 but \< 70 years old 2. Patients have provided voluntary written informed consent before performing any study-related procedure. 3. Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT). 4. Patients with documented symptomatic NDMM according to CRAB and/or SLIM criteria, with measurable disease as defined by: * Presence of ≥10% monoclonal plasma cells in the bone marrow OR presence of a biopsy-proven plasmacytoma. In addition, the patient must have ≥1 of the following myeloma defining events: \- Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than upper limits of normal (ULN) or \>2.75 mmol/L (\>11 mg/dL). \- Renal insuffi |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Lead sponsor | Intergroupe Francophone du Myelome |
| Locations | Amiens, France; Angers, France; Annecy, France; Argenteuil, France; Avignon, France; Bayonne, France (+58 more sites) |
| Start date | 2025-07-09 |
| NCT ID | NCT06918002 |
| Official listing | https://clinicaltrials.gov/study/NCT06918002 |