This phase II trial tests whether radiation therapy after B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) works to treat multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Radiation treatment may help to treat the disease and to decrease the symptoms from the disease and help the CAR-T cell treatment to work better.
Additional locations may be listed on ClinicalTrials.gov for NCT05336383.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Penny Q. Fang
Phone: 832-260-1389
PRIMARY OBJECTIVE:
I. To evaluate the preliminary efficacy of salvage radiation therapy after BCMA CAR-T cell therapy in subjects with relapsed and refractory multiple myeloma (RRMM).
SECONDARY OBJECTIVE:
I. Evaluate the safety of and other efficacy parameters of radiation treatment after BCMA CAR-T cell therapy in subjects with RRMM.
EXPLORATORY OBJECTIVES:
I. Evaluate the immunophenotype and/or expression profile, and perform functional bulk and single cell analysis of CAR T cells, endogenous T cells as well as other immune cells in the blood, bone marrow and/or tumor tissue with BCMA CAR-T therapy and radiation treatment (RT).
II. Evaluate changes in the levels of cytokines, chemokines, and soluble factors in the blood with BCMA CAR-T therapy and RT.
III. Evaluate changes in T cell receptor repertoire with BCMA CAR-T therapy and RT.
IV. Evaluate gut microbiome of patients treated with BCMA CAR-T therapy and RT.
OUTLINE:
Patients undergo radiation therapy to up to 5 treatment areas. Patients also undergo collection of blood throughout the trial.
After completion of study treatment, patients are followed up at 2 weeks, 3 months, 6 months, and 1, 2, 3, 4, and 5 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorPenny Q. Fang
