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

Launched by M.D. ANDERSON CANCER CENTER · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of radiation treatment for patients with relapsed and refractory multiple myeloma (RRMM) who have already received a specific type of therapy called BCMA CAR-T cell therapy. The goal is to see how safe and effective this salvage radiation treatment is for patients whose disease is still active after their CAR-T therapy. To be eligible for the trial, patients must be at least 18 years old, have been diagnosed with multiple myeloma, and must have shown signs of active disease on a scan at least 30 days after receiving CAR-T therapy. Additionally, they must have at least one area of myeloma that can be treated with radiation.

The study will involve 30 participants who will receive radiation treatment aimed at specific areas of their body affected by myeloma. Participants can expect to have their response to treatment monitored over six months to determine how well the radiation works in controlling their disease. It's important to note that patients who plan to start other chemotherapy treatments less than 14 days after radiation will not be eligible for this study. Overall, this trial aims to gather valuable information that could help improve treatment options for people with multiple myeloma.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• Subjects must satisfy the following criteria to be enrolled in the study:
• • 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
• • 2. Subject is diagnosed with multiple myeloma
• • 3. Subject previously received treatment with standard of care BCMA CAR-T cell therapy
• • 4. Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
• • 5. Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
• • 6. Able to provide informed consent
• Exclusion Criteria:
• The presence of any of the following will exclude a subject from enrollment:
• • 1. Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
• • 2. Subject is undergoing active treatment for another malignancy other than multiple myeloma
• • 3. Pregnant women will be excluded from this study.