drugset / Trial / NCT05405166

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Phase 3 Active not recruiting 531 enrolled Sanofi

RandomizedParallel-groupOpen-labelTreatment

Summary

This will be randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who will receive at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants were randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants are allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Timeline

Start: 2022-06-23
Primary completion: 2024-11-06
Completion: 2027-10-22

Outcome

Met primary endpoint

release “New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma” sanofi.com ↗

release “the pivotal IRAKLIA phase 3 non-inferiority study, which demonstrated Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy” sanofi.com ↗

Publications

Ailawadhi S, Spicka I, Spencer A, Lu J, Oriol A, Ling S, Schjesvold F, Berkovits A, Hus M, Li C, Dimopoulos MA, Rajnics P, Besisik SK, Hungria V, Custidiano MDR, Parmar G, Leleu X, Li F, Cerchione C, Gomez C, Ishida T, Mateos MV, Buck TT, LeBlanc R, Minarik J, Goldschmidt H, Zhang R, Semiond D, Suzan F, Stefanova-Urena M, Koch V, Moreau P. Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study. J Clin Oncol. 2025 Aug;43(22):2527-2537. doi: 10.1200/JCO-25-00744. Epub 2025 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isatuximab	Monoclonal antibody	10 mg/kg	Subcutaneous
Subject	Isatuximab	Monoclonal antibody	1400 mg	Subcutaneous
Background	Acetaminophen	Small molecule	—	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral
Background	Diphenhydramine	Small molecule	—	Oral
Background	Methylprednisolone	Other / unclassified	—	Intravenous
Background	Montelukast	Other / unclassified	—	Oral
Background	Pomalidomide	Other / unclassified	4 mg	Oral