NCT04045795

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	isatuximab SAR650984 IV	Pharmaceutical form: solution Route of administration: intravenous
DRUG	pomalidomide	Pharmaceutical form: tablet Route of administration: oral
DRUG	dexamethasone	Pharmaceutical form: tablet Route of administration: oral
DRUG	isatuximab SAR650984 SC	Pharmaceutical form: solution Route of administration: subcutaneous
DEVICE	Investigational injector device	Subcutaneous administration

Timeline

• Start date: 2019-08-06
• Primary completion: 2024-03-27
• Completion: 2024-03-27
• First posted: 2019-08-06
• Last updated: 2025-09-12

Locations

14 sites across 6 countries: United States, Australia, Belgium, France, Japan, Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study