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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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

Latest Information Update: 10 Jul 2019

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At a glance

  • Drugs Pomalidomide (Primary) ; Bortezomib; Bortezomib; Dexamethasone
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIMISMM
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 10 Jul 2019 Results presented in a Celgene Corporation media release.
    • 10 Jul 2019 According to a Celgene Corporation media release, based on this pivotal trial (OPTIMISMM), the Health Canada has approved a POMALYST (pomalidomide)-based triplet combination with bortezomib and dexamethasone. This is a new treatment option for patients with multiple myeloma (MM) who have received at least one prior treatment regimen that included REVLIMID (lenalidomide).
    • 16 May 2019 According to a Celgene Corporation media release, the approval of the IMNOVID triplet (PVd) by the European Commission (EC) was supported by data from this study (OPTIMISMM).
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