SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
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- STATUS
- Recruiting
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- End date
- Oct 23, 2026
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- participants needed
- 534
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- sponsor
- Sanofi
Summary
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.
Description
Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Details
| Condition | Plasma Cell Myeloma Recurrent |
|---|---|
| Treatment | Pomalidomide, Dexamethasone, Isatuximab IV, Isatuximab SC |
| Clinical Study Identifier | NCT05405166 |
| Sponsor | Sanofi |
| Last Modified on | 7 October 2022 |
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