Clinical Trial

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

Active, Not Recruiting Phase 2
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Record status
This record was last updated September 26, 2024 (before its estimated September 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2021-02-12; most recent amendment 2024-09-24.
Status change: Recruiting → Active, Not Recruiting 2024-09-24
Status change: Not Yet Recruiting → Recruiting 2023-01-12
Trial Details
NCT Number NCT04756401
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Enrollment 52 participants
Start Date 2022-12-08
Primary Completion 2024-09-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-26