A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Trial Profile

A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Suspended
Phase of Trial: Phase II

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Daratumumab (Primary) ; Durvalumab (Primary) ; Dexamethasone; Dexamethasone; Pomalidomide
  • Indications Multiple myeloma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms FUSIONMM-003
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 27 Sep 2017 Planned End Date changed from 30 Jun 2019 to 1 Nov 2019.
    • 27 Sep 2017 Planned primary completion date changed from 30 Sep 2018 to 20 Jun 2019.
    • 07 Sep 2017 According to a Celgene Corporation media release, the US FDA has placed a partial clinical hold on this trial, based on risks identified in other trials for an anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents.
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