A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"
M.D. Anderson Cancer Center
Summary
To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells.
Description
Primary Objectives To evaluate the efficacy of RT-induced immune priming to enhance Elranatamab (Elra) in RRMM with EMD or PMD as measured by overall response rate (ORR) at 3 months Secondary Objectives To describe adverse events (AEs). To determine time to next treatment (TTNT). To evaluate progression-free survival (PFS). To determine overall survival (OS). To estimate quality of life (QOL). To assess local control to the irradiated lesions To determine differences in response in patients with EMD vs PMD To determine differences in response in patients High Risk (HR) vs Standard Risk (SR) d…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * RRMM exposed to IMID, PI, anti-CD38 mAb, relapsed or refractory to at least one prior line of therapy (LOT), progressed on or after the last regimen: 1. Relapsed disease: progressive disease (PD) \>60 days after cessation of prior therapy 2. Refractory disease: PD \<=60 days after cessation of prior therapy, \<25% reduction in paraprotein (monoclonal protein \[M-protein\] or serum free light chains \[sFLC\]) or measurements of EMD/PMD * Diagnosis of relapsed or refractory multiple myeloma as indicated by progression by IMWG criteria * At least one locus of EMD or PMD…
Interventions
- DrugElranatamab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas