Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05336383

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

30

Participants Needed

1

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older at the time of informed consent
  • Diagnosed with multiple myeloma
  • Previously treated with standard of care BCMA CAR-T cell therapy
  • Active disease shown on PET or other imaging scan 30 days or later after CAR-T infusion
  • At least one bone or soft tissue plasmacytoma lesion suitable for radiation treatment
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Planned salvage chemotherapy less than 14 days after completing radiation treatment
  • Receiving active treatment for another cancer besides multiple myeloma
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

P

Penny Fang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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