A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
brief summary
This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.
detailed description
This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM) who have received ≥1 prior line of therapy and are double class exposed (lenalidomide and an anti-CD38). A safety-lead in will be employed for the first 6 evaluable participants (participants who have completed Cycle 1) (Cohort 1), followed by an expansion cohort (Cohort 2) of 40 participants. Eligible participants will receive a single prophylactic dose of tocilizumab followed by treatment with elranatamab. Tocilizumab, an interleukin-6 (IL-6) receptor antagonist, is approved for the treatment of Chimeric Antigen Receptor T-Cell (CAR-T)-associated CRS, and has shown promise in reducing CRS incidence when used prophylactically in bispecific antibody trials. Elranatamab is a bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, designed to redirect T cells to eliminate malignant plasma cells in multiple myeloma (MM).
official title
A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma (CORE-MM)