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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History