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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

Primary Objective:

The primary objective of the study is to evaluate the preliminary efficacy of salvage radiation therapy after BCMA CAR-T cell therapy in subjects with RRMM.

Secondary Objectives:

Evaluate the safety of and other efficacy parameters of radiation treatment after BCMA CAR-T cell therapy in subjects with RRMM

Exploratory Objectives:

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 RT

Evaluate changes in the levels of cytokines, chemokines, and soluble factors in the blood with BCMA CAR-T therapy and RT

Evaluate changes in T cell receptor repertoire with BCMA CAR-T therapy and RT

Evaluate gut microbiome of patients treated with BCMA CAR-T therapy and RT

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion criteria:

  • Subjects must satisfy the following criteria to be enrolled in the study:
    • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
    • Subject is diagnosed with multiple myeloma
    • Subject previously received treatment with standard of care BCMA CAR-T cell therapy
    • Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
    • Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
    • Able to provide informed consent

Exclusion Criteria:

  • The presence of any of the following will exclude a subject from enrollment:
    • Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
    • Subject is undergoing active treatment for another malignancy other than multiple myeloma
    • Pregnant women will be excluded from this study.
 

Additional Trial Information

Phase 2

Enrollment: 30 patients (estimated)

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Trial Locations

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Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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