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Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Oct 21, 2026 → Jul 29, 2027
See other at-risk trials from Roswell Park Cancer Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 21, 2026 to Jul 29, 2027
    • Study completion moved earlier from Sep 1, 2029 to Jul 29, 2027
    • Eligibility criteria revised
    • Publications: details revised at 2 of 2 entries
  2. Primary completion moved earlier from Dec 1, 2026 to Oct 21, 2026v33
  3. Study completion pushed from Sep 1, 2027 to Sep 1, 2029v32
  4. Primary completion pushed from Sep 1, 2026 to Dec 1, 2026v31
  5. Study completion pushed from Sep 1, 2026 to Sep 1, 2027v30
Show 28 earlier versionsHide 28 earlier versions
  1. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 4
    v29
  2. Trial status: Recruiting to Suspended Sponsor's reason: AE
    • Site details revised
    v28
  3. Re-verified, no change to tracked fieldsv27
  4. Start date changed from estimate of Sep 30, 2024 to Aug 19, 2024v26
  5. Start date: Jun 30, 2024 to Sep 30, 2024v25
  6. Start date: Apr 30, 2024 to Jun 30, 2024v24
  7. Start date: Mar 1, 2024 to Apr 30, 2024v23
  8. Primary and study completion dates: Feb 15, 2026 to Sep 1, 2026
    • Start date: Feb 15, 2024 to Mar 1, 2024
    v22
  9. Start date: Dec 15, 2023 to Feb 15, 2024
    • Primary and study completion dates: Dec 15, 2025 to Feb 15, 2026
    v21
  10. Start date: Oct 15, 2023 to Dec 15, 2023
    • Primary and study completion dates: Oct 15, 2025 to Dec 15, 2025
    v20
  11. Start date: Aug 15, 2023 to Oct 15, 2023
    • Primary and study completion dates: Jun 15, 2025 to Oct 15, 2025
    v19
  12. Start date: Jun 15, 2023 to Aug 15, 2023v18
  13. Start date: Apr 2023 to Jun 15, 2023v17 Show 4 more changesShow less
    • Primary completion date: Dec 30, 2024 to Jun 15, 2025
    • Study completion date: Dec 30, 2025 to Jun 15, 2025
    • Eligibility criteria revised
    • Study description shortened, about 5 words
  14. Start date: Feb 28, 2023 to Apr 2023v16
  15. Start date: Dec 30, 2022 to Feb 28, 2023v15
  16. Trial status: Not Yet Recruiting to Recruitingv14 Show 4 more changesShow less
    • Primary completion date: Sep 5, 2024 to Dec 30, 2024
    • Study completion date: Sep 5, 2025 to Dec 30, 2025
    • Start date: Dec 1, 2022 to Dec 30, 2022
    • Site details revised
  17. Start date: Oct 1, 2022 to Dec 1, 2022v13
  18. Start date: Sep 1, 2022 to Oct 1, 2022v12
  19. Start date: Jul 1, 2022 to Sep 1, 2022
    • Primary completion date: Jul 5, 2024 to Sep 5, 2024
    • Study completion date: Jul 5, 2025 to Sep 5, 2025
    v11
  20. Primary completion date: Jan 5, 2024 to Jul 5, 2024
    • Start date: May 1, 2022 to Jul 1, 2022
    • Study completion date: Dec 5, 2024 to Jul 5, 2025
    v10
  21. Collaborators expanded, about 1 wordv9
  22. Start date: Mar 1, 2022 to May 1, 2022v8
  23. Start date: Jan 15, 2022 to Mar 1, 2022v7
  24. Start date: Nov 15, 2021 to Jan 15, 2022
    • Primary completion date: Dec 5, 2023 to Jan 5, 2024
    v6
  25. Start date: Oct 1, 2021 to Nov 15, 2021v5
  26. Start date: Aug 1, 2021 to Oct 1, 2021v4
  27. Enrollment target: 19 to 20
    • Study description shortened, about 87 words
    • Eligibility criteria shortened, about 3 words
    v3
  28. Start date: Jun 1, 2021 to Aug 1, 2021v2
  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 II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.
Trial Details
NCT Number NCT04876248
Lead Sponsor Roswell Park Cancer Institute
Collaborators: GlaxoSmithKline
Conditions
(from sponsor)		 Plasma Cell Myeloma
Related terms Multiple Myeloma
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov