Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. Identify maximum tolerated dose of pelareorep in combination with other antineoplastic agents. II. Identify whether the combination of carfilzomib and nivolumab lead to a safety profile different than what has been reported with either agent independently. SECONDARY OBJECTIVES...

PRIMARY OBJECTIVES: I. Identify maximum tolerated dose of pelareorep in combination with other antineoplastic agents. II. Identify whether the combination of carfilzomib and nivolumab lead to a safety profile different than what has been reported with either agent independently. SECONDARY OBJECTIVES: I. Assess the relative roles of immune-mediated and direct cytotoxic myeloma cell killing. II. Understand the clinical benefit of nivolumab in programmed death-ligand 1 (PD-L1) positive multiple myeloma (MM) cells. OUTLINE: This is a dose-escalation study of pelareorep. Patients are assigned to 1 of 3 arms. ARM 1: Patients receive dexamethasone intravenously (IV) on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM 3 (expansion cohort): Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for a minimum of 4 weeks once off treatment or at least 100 days after the last nivolumab dose, then every 6 months after.

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