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: 07 Oct 2017

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

    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association.
    • 21 Jun 2017 According to an Amgen media release, data from this trial will pe presented at the 22nd Congress of the European Hematology Association (EHA).
    • 19 Jun 2017 According to an Amgen media release, the U.S. Food and Drug Administration has accepted the XGEVA (denosumab) supplemental Biologics License Application to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Feb. 3, 2018.
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