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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

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

    • 28 Oct 2016 According to a PharmaMar media release, based on the data from this study, the European Medicines Agency (EMA) has accepted to assess the Marketing Authorization Application (MAA) for Aplidin (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM).
    • 22 Sep 2016 According to a PharmaMar media release, based on the data from this study the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for plitidepsin in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM) and the response from the regulatory agency is anticipated in the second half of 2017.
    • 03 Jun 2016 Planned End Date changed from 1 Dec 2015 to 1 May 2017.
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