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: 06 Jun 2018

At a glance

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

    • 03 Apr 2018 According to Amgen media release, the European Commission (EC) has approved an expanded indication for XGEVA (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone.The approval is based on data from this trial.
    • 23 Feb 2018 According to an Amgen media release, an open-label extension of the study is ongoing.
    • 23 Feb 2018 The CHMP of the EMA has adopted a positive opinion to expand the current indication for XGEVA (denosumab) to cover skeletal-related events in patients with multiple myeloma. XGEVA will be indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. The application was based new data from this trial.
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