Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma

Summary

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Description

PRIMARY OBJECTIVE: I. To assess the rate of response following treatment with isatuximab combined with carfilzomib and pomalidomide (isatuximab [Isa] carfilzomib [Car] pomalidomide [Pom]). SECONDARY OBJECTIVES: I. To evaluate the safety profile of the IsaCarPom combination. II. To assess duration of...

PRIMARY OBJECTIVE: I. To assess the rate of response following treatment with isatuximab combined with carfilzomib and pomalidomide (isatuximab [Isa] carfilzomib [Car] pomalidomide [Pom]). SECONDARY OBJECTIVES: I. To evaluate the safety profile of the IsaCarPom combination. II. To assess duration of disease response following treatment with the IsaCarPom regimen. III. To assess depth of IsaCarPom treatment as it relates to timing of subsequent therapies. IV. To assess progression-free survival associated with IsaCarPom. V. To assess overall survival associated with IsaCarPom. EXPLORATORY OBJECTIVE: I. To molecularly assess the depth of IsaCarPom treatment by measuring minimal residual disease (MRD). OUTLINE: Patients receive isatuximab intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22 of cycle 1, and days 1 and 15 of subsequent cycles, carfilzomib IV over 10 to 30 minutes on days 1, 8, 15, and pomalidomide orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for up to 24 months.

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