SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
연구 개요
This is a 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 have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
- 스폰서
- 리드: 사노피
- 적응증
- Plasma Cell Myeloma Recurrent
- 중재
- Isatuximab IV, Isatuximab SC, Dexamethasone, Pomalidomide, Dexamethasone, Montelukast, Paracetamol / Acetaminophen, Diphenhydramine, Methylprednisolone
- 목표 등록
- 531명
- 시작일
- 2022-06-23
- 완료(예정)
- 2027-03-23
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