Last updated on August 2019

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

Brief description of study

Primary Objectives:

  • To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
  • 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 Study 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 approximately 14 months after first study treatment administration.

Clinical Study Identifier: NCT04045795

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