A Phase Ib study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma
Blood Mar 19, 2019
Mikhael J, et al. - In order to evaluate the safety and recommended dose of isatuximab plus pomalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM), researchers performed this phase Ib dose-escalation study including 45 patients who had received ≥2 prior MM therapies, including lenalidomide and a proteasome inhibitor (PI). The patients were administered isatuximab at 5, 10, or 20 mg/kg (weekly [QW] for 4 weeks, followed by every 2 weeks [Q2W]), pomalidomide 4 mg (Days 1–21), and dexamethasone 40 mg (QW) in 28-day cycles until progression/intolerable toxicity. As per outcomes, isatuximab plus pomalidomide/dexamethasone show potential meaningful clinical activity and a manageable safety profile in heavily pre-treated patients with RRMM. They selected the 10 mg/kg QW/Q2W isatuximab dose for future studies.
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