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

Summary

The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.

Timeline

Start

2023-04-05

Primary completion

2025-12-22

Completion

2028-05-12

Outcome

Met primary endpoint

paper The study met its primary efficacy endpoint with a 79.7% overall response rate (N = 74), at a median follow-up of 10.1 months. PMID 41455697 ↗

Publications

• Parmar G, Capra M, Seguro F, Hungria V, Dimopoulos MA, Delimpasi S, Minarik J, Spicka I, Pour L, Marques H, Esteves G, Sunami K, Yuda J, Hajek R, Mihalyova J, Soufflet C, Yu D, Benlhassan K, Koch V, Comerford E, Cordero P, Suzan F, Quach H. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025 Dec 27;16(1):16. doi: 10.1038/s41408-025-01436-0.

Drugs

Indications