Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
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