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Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

Study acronym: IFM2017_03
StatusCompleted
PhasePhase 3
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Oct 7, 2026 to Aug 28, 2026
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Site details revised at 1 of 23 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Oct 2026 to Oct 7, 2026
    • Study completion date: Oct 2027 to Oct 7, 2026
    • Publications: details revised at 1 of 1 entry
    v7
  3. 2 versions Re-verified since Mar 12, 2024, no change to tracked fieldsv5-v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 3 to 23
    v4
  5. Eligibility criteria shortened, about 16 wordsv3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 3
    • Primary completion date: Sep 1, 2026 to Oct 2026
    • Study completion date: Sep 1, 2027 to Oct 2027
    • Start date changed from estimate of Sep 1, 2019 to Oct 17, 2019
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT
Trial Details
NCT Number NCT03993912
Lead Sponsor University Hospital, Lille
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov