Status:
RECRUITING
Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Multiple Myeloma
Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 sub...
Detailed Description
Objectives 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. Secondar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05336383
Start Date
May 31 2022
End Date
December 7 2026
Last Update
October 9 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030