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Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Results first posted: Jul 28, 2026
    • Study completion pushed from May 2, 2026 to Sep 2, 2026
    v20
  2. Study completion date: May 2, 2026 to Sep 2, 2026v19
  3. Secondary endpoints revised (10)
    • Primary endpoint revised
    v18
  4. Primary completion date changed from estimate of Aug 2024 to May 2, 2024
    • Study completion date: Aug 2026 to May 2, 2026
    v17
  5. Primary completion date: Feb 2024 to Aug 2024
    • Study completion date: Feb 2026 to Aug 2026
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Re-verified, no change to tracked fieldsv15
  2. Primary completion date: Oct 2023 to Feb 2024
    • Study completion date: Oct 2025 to Feb 2026
    v14
  3. Trial status: Recruiting to Active, Not Recruitingv13 Show 4 more changesShow less
    • Enrollment target: estimated 50 to confirmed 57
    • Primary completion date: Oct 2024 to Oct 2023
    • Study completion date: Oct 2026 to Oct 2025
    • Site details revised at 4 of 4 sites
  4. Site details revised at 2 of 4 sitesv12
  5. Eligibility criteria shortened, about 9 wordsv11
  6. Study completion date: Oct 2025 to Oct 2026
    • Site details revised at 1 of 4 sites
    v10
  7. Eligibility criteria expanded, about 47 wordsv9
  8. Study sites: 1 to 4
    • Study title expanded, about 10 words
    v8
  9. Re-verified, no change to tracked fieldsv7
  10. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Sep 2024 to Oct 2024
    • Study completion date: Sep 2025 to Oct 2025
    • Start date changed from estimate of Sep 2020 to Oct 5, 2020
    • Site details revised
  11. Start date: Jun 2020 to Sep 2020
    • Primary completion date: Jun 2024 to Sep 2024
    • Study completion date: Jun 2025 to Sep 2025
    v5
  12. Start date: Apr 2020 to Jun 2020
    • Primary completion date: Apr 2024 to Jun 2024
    • Study completion date: Apr 2025 to Jun 2025
    v4
  13. Start date: Feb 2020 to Apr 2020
    • Primary completion date: Feb 2024 to Apr 2024
    • Study completion date: Feb 2025 to Apr 2025
    v3
  14. Start date: Dec 2019 to Feb 2020
    • Primary completion date: Dec 2023 to Feb 2024
    • Study completion date: Dec 2024 to Feb 2025
    v2
  1. 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 phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.
Trial Details
NCT Number NCT04140162
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Janssen Scientific Affairs, LLC
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov