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Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

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Trial Profile

Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jul 2024

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At a glance

  • Drugs Plitidepsin (Primary) ; Dexamethasone
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms ADMYRE
  • Sponsors PharmaMar

    • Most Recent Events

    • 08 Jul 2024 According to a PharmaMar media release, the company will demand the reassessment process to be conducted with absolute impartiality, equality and transparency by the EMA.
    • 08 Jul 2024 According to a PharmaMar media release, the company has received a notification from the European Commission (EC) informing the Company of its decision to revoke the refusal to grant Marketing Authorization for Aplidin in Multiple Myeloma, According to the communication received, the EC has reevaluated the criteria applied for the participation of experts in the administrative procedure for the Marketing Authorization of Aplidin, as well as the relevant EMA rules governing conflicts of interest
    • 01 Sep 2019 Results efficacy and safety of plitidepsin in combination with dexamethasone vs. dexamethasone alone in patients with relapsed/refractory multiple myeloma, published in the Annals of Hematology.

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