Daratumumab (HuMax-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study

Trial Profile

Daratumumab (HuMax-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study

Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Oct 2017

At a glance

  • Drugs Daratumumab (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Genmab; Janssen-Cilag
  • Most Recent Events

    • 12 Oct 2017 Results evaluating the effect of daratumumab alone or in combination with lenalidomide-dexamethasone using data from GEN501 and GEN503 trials published in the Clinical cancer research: an official journal of the American Association for Cancer Research.
    • 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
    • 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.
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