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NCT06822972 · ClinicalTrials.gov registry record · Phase 2
HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM
A Phase 2 study of Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT06822972 is a Phase 2 study of Multiple Myeloma in Relapse and Multiple Myeloma, Refractory that is actively recruiting participants, run by Duke University. The registered enrollment target is 27 participants, below the 49-participant average among 12 other Multiple Myeloma in Relapse trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06822972, a Phase 2 study of Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy. The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken. Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
Conditions Studied
Interventions
- DRUG Selinexor 40 mg
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-08-22 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06822972
The ClinicalTrials.gov registry entry for NCT06822972 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 49-participant average among 12 other Multiple Myeloma in Relapse trials with a reported enrollment target (45% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Myeloma in Relapse appearing as the primary indexed condition, and to 1 intervention - of which Selinexor 40 mg is the first listed.
NCT06822972 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06822972 about?
NCT06822972 is a clinical study titled "HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM". The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy. T...
What is the current status of trial NCT06822972?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2025-08-22. Estimated completion is 2027-12-31.
What conditions does trial NCT06822972 study?
This clinical trial studies the following conditions: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory.
What interventions are being tested in trial NCT06822972?
The interventions under investigation include: Selinexor 40 mg (DRUG).
Who is sponsoring clinical trial NCT06822972?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06822972 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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