Trial Identifiers
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Scientific Title
A Phase 2, Open Label, Multicenter, Single-stage Study to Evaluate the Efficacy of Isatuximab Plus Pomalidomide and Dexamethasone (IPd), in Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy
Cooperative Group
Intergroupe Francophone du Myelome
Summary
This is a non-randomised, open-label trial for people with AL Amyloidosis Not in VGPR or Better After Any Previous Therapy. There is one experimental arm. All participants will receive 9 to 12 cycles of intravenous (IV) Isatuximab (10 mg/kg) and oral Pomalidomide 4 mg from day 1 to day 21 and Dexamethasone 10-20 mg weekly on days 1, 8, 15 and 22. Each cycle will be of 28 days duration. During cycle 1, Isatuximab will be administered weekly on days 1, 8, 15, and 22 then days 1 and 15 in subsequent cycles from cycle 2 to 9 or 12.