Phase 2 Study of Subcutaneous Isatuximab with Weekly Carfilzomib and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the effectiveness of subcutaneous isatuximab delivered via an on-body delivery system combined with weekly carfilzomib and dexamethasone in adults with relapsed or refractory multiple myeloma who have had 1 to 3 prior treatments. This Phase 2, single-arm, open-label study aims to assess the overall response rate to this combination treatment for this condition. Participants will receive isatuximab subcutaneously on specific days within each 28-day cycle days 1, 8, 15, and 22 during the first cycle, and days 1 and 15 for subsequent cycles. Carfilzomib is given intravenously starting with a dose on day 1 of cycle 1, followed by escalated doses on days 8 and 15, then on days 1, 8, and 15 in later cycles. Dexamethasone is administered intravenously or orally on designated days throughout each cycle. Treatment continues for up to 12 months unless stopped early. Before treatment, participants undergo a screening period lasting up to 28 days. After finishing treatment, there is an end-of-treatment visit about 30 days after the last dose, followed by a study follow-up period lasting until death or the studys final cutoff date. Researchers will monitor response rates, side effects such as infusion or injection site reactions, laboratory changes, and patient satisfaction. Some participants will have additional blood tests to measure drug levels and immune responses.

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma