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NCT05336383 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05336383 is a Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05336383, a Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a Phase II study to determine the preliminary safety and efficacy of salvage radiation treatment after BCMA CAR-T therapy in subjects with RRMM. The study population will consist of subjects with RRMM previously treated with SOC BCMA CAR-T cell therapy with active disease on the D30+ PET or other imaging scan after CAR-T infusion. Patients who are planned for salvage chemotherapy less than 14 days after completion of radiation treatment will be excluded. Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy). Final dose, target, and technique are per treating radiation physician discretion within these guidelines. Thirty patients will be enrolled. The co-primary endpoints are objective response rate (ORR) at 6 months and duration of response (DOR) among responders.
Conditions Studied
Interventions
- DRUG Radiation Therapy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-31 |
| Est. Completion | 2026-12-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05336383
The ClinicalTrials.gov registry entry for NCT05336383 describes a study currently listed as 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 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Radiation Therapy is the first listed.
NCT05336383 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05336383 about?
NCT05336383 is a clinical study titled "Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma". This study is a Phase II study to determine the preliminary safety and efficacy of salvage radiation treatment after BCMA CAR-T therapy in subjects with RRMM. The study population will consist of subjects with RRMM previously treated with SOC BCMA CAR-T cell therapy with active disease on the D30+ ...
What is the current status of trial NCT05336383?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-05-31. Estimated completion is 2026-12-07.
What conditions does trial NCT05336383 study?
This clinical trial studies the following conditions: Multiple Myeloma, Plasma Cell Neoplasm, Malignant Plasma Cell Neoplasm.
What interventions are being tested in trial NCT05336383?
The interventions under investigation include: Radiation Therapy (DRUG).
Who is sponsoring clinical trial NCT05336383?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05336383 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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