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NCT04756401 · ClinicalTrials.gov registry record · Phase 2
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
A Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 4
- Study locations
NCT04756401 is a Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 52 participants, above the 45-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (16% higher). The trial reports 4 study locations across 3 states.
The verdict
NCT04756401, a Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Selinexor
- DRUG Dexamethasone
- BIOLOGICAL Daratumumab
- DRUG Carfilzomib
Study Locations (4)
North Carolina
- UNC Lineberger Comprehensive Cancer Center University of North Carolina at Chapel Hill - Chapel Hill
- Carolinas Medical Center/Levine Cancer Institute - Charlotte
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- State University of New York Upstate Medical University - Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04756401
The ClinicalTrials.gov registry entry for NCT04756401 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (16% higher). The listed sponsor is Academic and Community Cancer Research United, which has 42 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04756401 reports 4 study locations spanning 3 distinct geographic areas - top geographies include North Carolina, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT04756401 about?
NCT04756401 is a clinical study titled "Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma". 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. Seli...
What is the current status of trial NCT04756401?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2022-12-08. Estimated completion is 2027-12-30.
What conditions does trial NCT04756401 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma.
What interventions are being tested in trial NCT04756401?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Selinexor (DRUG), Dexamethasone (DRUG), Daratumumab (BIOLOGICAL), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT04756401?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04756401 being conducted?
This trial has 4 study locations across New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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