This phase II trial tests how well radiation therapy induced immune priming to enhance how well elranatamab works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) with extramedullary disease and paramedullary disease. Patients with extramedullary and paramedullary disease represent a critical unmet need in the management of multiple myeloma. These disease manifestations are associated with aggressive biology and marked resistance to standard therapies, resulting in poor survival outcomes. Extramedullary disease involves the infiltration of organs and soft tissues by malignant (clonal) plasma cells, most frequently affecting the skin, liver, lymph nodes, pleura, and central nervous system. Paramedullary disease refers to soft tissue plasma cell tumors that grow directly from the bone into surrounding tissue. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink cancers. A monoclonal antibody, such as elranatamab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving the combination of radiation therapy and elranatamab may help to better control relapsed or refractory multiple myeloma that has spread outside of the bone marrow.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07382739.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Jing Christine Ye
Phone: 832-748-6369
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of radiation therapy (RT)-induced immune priming to enhance elranatamab (Elra) in relapsed refractory multiple myeloma (RRMM) with extramedullary disease (EMD) or paramedullary disease (PMD) as measured by overall response rate (ORR) at 3 months.
SECONDARY OBJECTIVES:
I. To describe adverse events (AEs).
II. To determine time to next treatment (TTNT).
III. To evaluate progression-free survival (PFS).
IV. To determine overall survival (OS).
V. To estimate quality of life (QOL).
VI. To assess local control to the irradiated lesions.
VII. To determine differences in response in patients with EMD versus (vs) PMD.
VIII. To determine differences in response in patients High Risk (HR) vs Standard Risk (SR) disease.
OUTLINE:
STEP-UP PERIOD: Patients undergo radiation therapy once daily (QD) for 10 treatment fractions on days -14 to 5, and receive elranatamab subcutaneously (SC) on days 1 and 3 for up to 2 step-up doses in the absence of unacceptable toxicity.
SUBSEQUENT TREATMENT: Starting 2- 6 days after step up dose 2, patients receive elranatamab SC on day 6 of cycle 0, and then once a week (QW) of cycle 1, once every two weeks (Q2W) of cycles 2 and 3 and once every 4 weeks (Q4W) of subsequent cycles. If the patient does not achieve very good partial response or better (VGPR+) after cycle 3, Q2W may be continued through cycles 4-6. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and brain magnetic resonance imaging (MRI) during screening. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET)/CT, blood sample collection, bone marrow biopsy and aspiration, and image-guided EMD biopsy throughout the trial.
After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJing Christine Ye
