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Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Sep 30, 2024 to Aug 29, 2025
    • Results posted: Sep 15, 2026
    • Final enrollment: 8 participants (planned 52)
    v16
  2. Primary completion date changed from estimate of Sep 30, 2024 to Aug 29, 2025
    • Enrollment target: estimated 52 to confirmed 8
    • Secondary endpoints revised (7)
    • Primary endpoint revised
    v15
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 11 to 4
    v14
  4. Study sites: 10 to 11v13
  5. Site details revised at 1 of 10 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Dec 30, 2023 to Sep 30, 2024v11
  2. Site details revised at 1 of 10 sitesv10
  3. Study sites: 9 to 10v9
  4. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Sep 30, 2023 to Dec 30, 2023
    • Study completion date: Sep 30, 2027 to Dec 30, 2027
    • Start date changed from estimate of Oct 31, 2022 to Dec 8, 2022
    • Site details revised at 9 of 9 sites
  5. Start date: Aug 31, 2022 to Oct 31, 2022
    • Site contacts updated at 2 of 9 sites
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Study sites: 8 to 9v5
  8. Start date: Aug 31, 2021 to Aug 31, 2022v4
  9. Start date: May 31, 2021 to Aug 31, 2021v3
  10. Start date: Mar 31, 2021 to May 31, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 studies the effect of selinexor when combined with carfilzomib, daratumumab, and dexamethasone in treating patients with high-risk multiple myeloma that has come back (recurrent) or has not responded to treatment (refractory) and who have received 1-3 prior lines of therapy. Selinexor may stop the growth of cancer cells by blocking a protein called CRM1 that is needed for cell growth. Carfilzomib is a type of drug called a proteasome inhibitor. A proteasome is a protein found within cells that has the important role of identifying and marking damaged proteins that are needed to be destroyed by the cell for survival. The inhibition of the proteasome allows for damaged protein to accumulate within cells. This accumulation of damaged protein causes the cell to die. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving selinexor in combination with carfilzomib, daratumumab, and dexamethasone may work better than carfilzomib, daratumumab, and dexamethasone alone in treating patients with multiple myeloma.
Trial Details
NCT Number NCT04756401
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Related terms Multiple Myeloma
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov