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

About the trial

Sponsor

Sanofi

Tested

Isatuximab IV (drug), Isatuximab SC (drug), Dexamethasone (drug), Pomalidomide (drug), Dexamethasone (drug), Montelukast (drug), Paracetamol / Acetaminophen (drug), Diphenhydramine (drug), Methylprednisolone (drug)

Dates

Started 2022-06-23; completion 2027-10-22

Results posted

Yes

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.

From ClinicalTrials.gov, last updated 2026-09-02. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $1.3M in research payments for this study in 2025 (201 payments).

Products named: Sarclisa

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.