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

Completed
Phase of Trial: Phase II

Latest Information Update: 05 Oct 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

    • 05 Oct 2017 Results (n=228) of exploratory analysis assessing the influence of disease and patient characteristics on exposure to daratumumab and clinical outcomes using patient data from GEN501 and SIRIUS trials published in the Clinical Pharmacokinetics
    • 09 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 03 Aug 2017 This trial has been completed in Belgium.
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