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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: Active Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by Academic and Community Cancer Research United.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MRD negative status at 10\^-5 level of sensitivity by flow cytometry will be considered synonymous with "success", unless specified otherwise. The proportion of success will be estimated by the number of success divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
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 |
What the registry record for NCT04756401 still lists
NCT04756401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, above the 45-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (16% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04756401's enrollment target sits among peer trials
52 6th of 25 higher than 20 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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