Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Minor Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 9 words
    • Site details revised
    • Study description expanded, about 4 words
  2. Minor 3 versions Re-verified since Apr 24, 2025, no change to tracked fieldsv9-v11
  3. Notable Primary and study completion dates: Dec 7, 2024 to Dec 7, 2026v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary and study completion dates: Dec 7, 2023 to Dec 7, 2024v6
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  1. Minor 2 versions Re-verified since Jul 9, 2022, no change to tracked fieldsv4-v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 31, 2022 to May 31, 2022
    • Site details revised
    v3
  3. Minor Study title shortened, about 3 wordsv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05336383
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)
Multiple Myeloma, Plasma Cell Neoplasm, Malignant Plasma Cell Neoplasm
Related terms Multiple Myeloma, Neoplasms, Plasma Cell
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov