Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Total study duration is variable depending on treatment and follow-up periods, including 21 days of screening, and treatment period until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of investigational medicinal product, or before further anti-myeloma therapy, whichever comes first; approximately 14 months after first study treatment administration.

A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Primary Objectives: To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: To estimate absolute bioavailability of SC and IV isatuximab To measure receptor occupancy (RO) after isatuximab SC versus IV administration To assess efficacy of isatuximab after SC and IV administration To assess patient expectations prior to and patient experience and satisfaction after SC administration To evaluate potential immunogenicity of SC or IV isatuximab

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Recruitment

Summary

Participation Requirements

Description

Tracking Information