Clinical summary
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive isatuximab administered via subcutaneous injection weekly for 4 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of subsequent cycles. In the Active Comparator Arm, participants will receive isatuximab administered via intravenous infusion weekly for 3 weeks during Cycle 1 (Days 1, 8, 15 and 22) and Day 1 and 15 of each subsequent cycle. Each cycle will be 28 days in duration. All participants will also receive pomalidomide, to be taken orally on Day 1 to Day 21 of each cycle at the time that is is most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day, as well as dexamethasone to betaken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).Age
18+
More information
Trial Identifiers
Use the hyperlinks, where available to access additional clinical trial information.
Commercial Sponsor
Sanofi
Scientific Title
A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)