An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or are Double Refractory to a Proteasome Inhibitor and an IMiD

Trial Profile

An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or are Double Refractory to a Proteasome Inhibitor and an IMiD

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Daratumumab (Primary)
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms SIRIUS
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 03 Aug 2017 This trial has been completed in Belgium.
    • 01 Aug 2017 Results of pooled analysis assessing comparison of Daratumumab monotherapy in GEN501 and SIRIUS study versus real world two independent US databases ;IMS-LifeLink and OPTUM, presented in American Journal of Hematology.
    • 08 Jul 2017 This trial has been completed in Spain.
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