At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating isatuximab SAR650984 IV, pomalidomide, and 3 other interventions for Multiple Myeloma. Completed, enrolled 56 participants across 14 sites in 6 countries.
Detailed 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
Study Details
Timeline
Interventions
Pharmaceutical form: solution Route of administration: intravenous
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: solution Route of administration: subcutaneous
Subcutaneous administration