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A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

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Trial Profile

A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2026

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At a glance

  • Drugs Isatuximab (Primary) ; Dexamethasone; Dexamethasone; Pomalidomide
  • Indications Multiple myeloma; Plasmacytoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ICARIA; ICARIA-MM
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

Most Recent Events

  • 22 Apr 2026 According to a Sanofi media release, The US FDA has extended by up to three months the target action date for its review of the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved US indications of Sarclisa intravenous (IV) formulation. The revised target action date for the FDA decision is July 23, 2026.
  • 31 Jan 2025 According to a Sanofi media release, based on the ICARIA-MM phase 3 study, Sarclisa is approved in the Japan in combination with Pd for the treatment of patients with R/R MM who have received greater than two prior therapies, including lenalidomide and a proteasome inhibitor.
  • 13 Jan 2025 According to a Sanofi media release, based on data form this trial and China-based IsaFiRsT real-world study as bridging data, the National Medical Products Administration (NMPA) in China has approved Sarclisa, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

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