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

Study acronym: ElLen
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary endpoints: details revised at 3 of 4 entries Trial sites expanded: 64 → 69 locations · Eligibility criteria shortened, about 8 words · Secondary endpoints: details revised at 6 of 8 entries Show 3 more changesShow less
    • Trial sites expanded: 64 → 69 locations
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 6 of 8 entries
  2. Minor Study sites revised (64)v6 See this version in full on ClinicalTrials.gov ↗
  3. Minor Eligibility criteria expanded, about 49 words Site details revised at 16 of 64 sitesv5 Show 1 more changeShow less
    • Site details revised at 16 of 64 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study sites revised (64)v4 See this version in full on ClinicalTrials.gov ↗
  5. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 64 · Start date changed from estimate of Jun 2025 to Jul 9, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 64
    • Start date changed from estimate of Jun 2025 to Jul 9, 2025
  6. Minor Start date: May 2025 to Jun 2025v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06918002
Lead Sponsor Intergroupe Francophone du Myelome
Collaborators: Pfizer
Conditions Multiple Myeloma, Newly Diagnosed
Enrollment 824 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov