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Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v9
  3. Trial status: Recruiting to Suspended Sponsor's reason: Implementation Issues
    • Site details revised
    v8
  4. Eligibility criteria shortened, about 4 wordsv7
  5. Primary completion date: Apr 1, 2027 to May 1, 2027
    • Study completion date: Apr 1, 2030 to May 1, 2030
    • Start date changed from estimate of May 16, 2025 to May 1, 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria expanded, about 75 wordsv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 1, 2025 to May 16, 2025
    • Study sites: 0 to 1
    v4
  3. Start date: Feb 1, 2025 to Apr 1, 2025
    • Primary completion date: Nov 1, 2026 to Apr 1, 2027
    • Study completion date: Nov 1, 2029 to Apr 1, 2030
    v3
  4. Start date: Nov 1, 2024 to Feb 1, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 studies how well mezigdomide/carfilzomib/dexamethasone (MeziKD) works in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and have tumors from myeloma cells outside the bone marrow in the soft tissues or organs of the body (extramedullary disease \[EMD\]). Mezigdomide blocks important processes in myeloma cells and may lead to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a type of corticosteroid and is used to kill myeloma cells. It is used with other drugs to treat multiple myeloma. Giving MeziKD may kill more cancer cells in patients with relapsed/refractory multiple myeloma (RRMM) with EMD.
Trial Details
NCT Number NCT06627751
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)		 Extramedullary Disease in Multiple Myeloma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov