RecruitingPhase 2NCT05336383

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

May 31, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether radiation treatment aimed at remaining cancer spots can help people with multiple myeloma whose disease came back or is still active after receiving a type of advanced immunotherapy called BCMA CAR-T cell therapy. **You may be eligible if...** - You are 18 years or older - You have multiple myeloma and already received standard BCMA CAR-T therapy - A scan taken 30 or more days after your CAR-T infusion shows active cancer remaining - You have at least one myeloma lesion in bone or soft tissue that can be targeted with radiation - You are able to give informed consent **You may NOT be eligible if...** - You are scheduled for salvage chemotherapy within 14 days of finishing radiation - You do not have a targetable lesion for radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRadiation Therapy

Given by Infusion


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05336383


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