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NCT05801939 · ClinicalTrials.gov registry record · Phase 2
Cevostamab Following CAR T Cell Therapy for RRMM
A Phase 2 study of Relapsed/Refractory Multiple Myeloma, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05801939: Active Phase 2 study of Relapsed/Refractory Multiple Myeloma, sponsored by University of Pennsylvania.
NCT05801939 is a Phase 2 study of Relapsed/Refractory Multiple Myeloma that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 30 participants, below the 177-participant average among 9 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05801939, a Phase 2 study of Relapsed/Refractory Multiple Myeloma, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2, open-label, single-arm, single stage, single-institution study, with an initial safety run-in period. Potential participants with relapsed/refractory myeloma who are undergoing standard of care, commercially-available BCMA-directed CAR T cell therapy may be identified pre-CAR T cell infusion but are not consented and enrolled until at least 4-6 weeks after CAR T cell infusion, once recovered from acute toxicities. Note: the lymphodepleting chemotherapy and CAR T cell therapy is being administered as part of standard clinical practice and is not considered part of this protocol. Alternative lymphodepleting regimens other than fludarabine and cyclophosphamide (eg in the setting of fludarabine shortages) are acceptable. Cevostamab will be given as an IV infusion once every 3 weeks, starting roughly 10 weeks (day 70 +/- 4 days) post-CAR T cell infusion, with subjects planned to receive 8 cycles initially. Aiming to assess the impact of cevostamab consolidation post-BCMA CAR T cell therapy on rate of MRD-negative complete remission (CR) at 12 months.
Conditions Studied
Interventions
- DRUG Cevostamab
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05801939
The ClinicalTrials.gov registry entry for NCT05801939 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 9 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (83% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Cevostamab is the first listed.
NCT05801939 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05801939 about?
NCT05801939 is a clinical study titled "Cevostamab Following CAR T Cell Therapy for RRMM". This is a Phase 2, open-label, single-arm, single stage, single-institution study, with an initial safety run-in period. Potential participants with relapsed/refractory myeloma who are undergoing standard of care, commercially-available BCMA-directed CAR T cell therapy may be identified pre-CAR T ce...
What is the current status of trial NCT05801939?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-07-11. Estimated completion is 2028-05.
What conditions does trial NCT05801939 study?
This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.
What interventions are being tested in trial NCT05801939?
The interventions under investigation include: Cevostamab (DRUG).
Who is sponsoring clinical trial NCT05801939?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05801939 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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