Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
Summary
Third Opinion Trial Synopsis:
This study is for people with a type of cancer called RRMM who have already received a specific treatment called BCMA CAR-T therapy but still have active cancer. The study wants to see if it is safe and helpful to use radiation treatment after the BCMA CAR-T therapy. The study will only include patients who will not start chemotherapy within 14 days after radiation treatment. The radiation treatment will be given to specific parts of the body and the amount will be decided by the doctor treating the patient. The study will enroll 30 patients and will look at how well the cancer responds to the treatment after 6 months and how long the response lasts.
This study is for people with a type of cancer called RRMM who have already received a specific treatment called BCMA CAR-T therapy but still have active cancer. The study wants to see if it is safe and helpful to use radiation treatment after the BCMA CAR-T therapy. The study will only include patients who will not start chemotherapy within 14 days after radiation treatment. The radiation treatment will be given to specific parts of the body and the amount will be decided by the doctor treating the patient. The study will enroll 30 patients and will look at how well the cancer responds to the treatment after 6 months and how long the response lasts.
*Third Opinion AI Generated Synopsis
Trial 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.
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.
Locations & Contact
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