Phase II Study of Radiation Treatment After CAR-T Therapy for Relapsed Refractory Multiple Myeloma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05336383
This clinical trial is exploring the safety and effectiveness of using radiation therapy after CAR-T cell treatment in patients with relapsed or refractory multiple myeloma. The study focuses on patients whose disease remains active after initial CAR-T therapy.
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Program Overview
This study aims to find out if radiation therapy can be safely and effectively used after CAR-T cell treatment in patients with relapsed or refractory multiple myeloma (RRMM). The trial will include patients who have already received standard CAR-T therapy but still show active disease on scans. Radiation will target specific areas of cancer in the bones or soft tissues. The study will enroll 30 patients and will measure how well the cancer responds to this treatment and how long the response lasts.
Description
The main goal of this study is to see if radiation therapy can help control multiple myeloma after CAR-T cell treatment. Researchers will also look at the safety of this approach and other effects it may have. Additionally, the study will explore how the immune system responds to this combination of treatments by analyzing blood, bone marrow, and tumor samples. This includes looking at changes in immune cells, proteins, and gut bacteria.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with multiple myeloma.
- Previously treated with standard CAR-T cell therapy targeting BCMA.
- Show active disease on a PET scan or other imaging after CAR-T treatment.
- Have at least one myeloma lesion that can be treated with radiation.
- Able to provide informed consent.
Exclusion Criteria
- Planning to start chemotherapy less than 14 days after finishing radiation treatment.
- Currently receiving treatment for another type of cancer besides multiple myeloma.
- Pregnant women are not eligible for this study.
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