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Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma

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Trial Profile

Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Aug 2026

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At a glance

  • Drugs Bortezomib (Primary) ; Dexamethasone (Primary) ; Isatuximab (Primary) ; Lenalidomide (Primary)
  • Indications Multiple myeloma
  • Focus Therapeutic Use
  • Acronyms ISASOCUT

Most Recent Events

  • 02 May 2026 Planned End Date changed from 1 Jul 2028 to 1 Sep 2028.
  • 27 Mar 2026 According to a Sanofi media release, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) for the treatment of patients with multiple myeloma (MM).
  • 05 Sep 2024 Planned primary completion date changed from 1 Jul 2024 to 1 Jul 2026.

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