A Phase 2 Study of Elranatamab in Combination With Isatuximab in Relapsed and Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating elranatamab combined with isatuximab given as injections under the skin for patients with relapsed and refractory multiple myeloma RRMM who have had at least two prior treatments including immunomodulatory drugs and proteasome inhibitors. This phase 2, open-label study aims to see if these study drugs reduce disease worsening and to assess their possible risks. Isatuximab is normally given intravenously but will be given subcutaneously using a new delivery device that is being studied. Participants will receive elranatamab injections into the abdomen or lower stomach on specific days in 28-day treatment cycles, with more frequent dosing in the first cycle and less frequent in later cycles. Isatuximab will be given subcutaneously using an investigational on-body delivery system device during certain visits starting from the second cycle. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The first six patients will be closely monitored for safety before enrolling others. During the study, participants will have an initial inpatient stay of 2 to 8 days for close monitoring of the first dose. Follow-up visits will occur every three months for up to five years after treatment ends. Researchers will assess outcomes including the objective response rate, drug-related toxicities, progression-free survival, overall survival, and minimal residual disease status. Regular safety assessments and evaluations will be conducted throughout the study.

ELISA in Relapsed/Refractory MM