A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma

Trial Profile

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2018

At a glance

  • Drugs Denosumab (Primary) ; Zoledronic acid
  • Indications Bone disorders; Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen; Daiichi Sankyo Inc
  • Most Recent Events

    • 05 Jan 2018 Results presented in an Amgen Media Release.
    • 05 Jan 2018 According to an Amgen media release, based on the data from this study, U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association.
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