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

  • STATUS
    Not Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    56
  • sponsor
    Sanofi
Updated on 13 May 2022
measurable disease
dexamethasone
lenalidomide
refractory multiple myeloma

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

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.

Details
Condition Multiple Myeloma
Treatment Pomalidomide, Dexamethasone, isatuximab SAR650984, isatuximab SAR650984 IV, isatuximab SAR650984 SC, Investigational injector device
Clinical Study IdentifierNCT04045795
SponsorSanofi
Last Modified on13 May 2022

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