Denosumab in Patients with Newly Diagnosed Multiple Myeloma
Research type
Research Study
Full title
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
IRAS ID
80171
Contact name
Atul Mehta
Sponsor organisation
Amgen Inc
Eudract number
2010-020454-34
Clinicaltrials.gov Identifier
Research summary
This is a phase 3, global, multicentre study. Patients with newly diagnosed multiple myeloma and at least one bone lesion will be able to take part. Approximately 760 patients will be recruited (allocated into groups by chance) in a 1:1 ratio to one of the following treatment arms: ?½ Arm A: SC injection of Denosumab and an IV infusion of zoledronic acid placebo Q4W ?½ Arm B: SC injection of Denosumab placebo and an IV infusion of zoledronic acid Q4W All patients will have a 100% chance of receiving active treatment with either Denosumab or Zoledronic acid. The placebo is a dummy treatment containing no active ingredient. This study is double-blind which means neither the patient, investigator or sponsor will know which of the 2 treatment arms the patient is receiving. All patients will also receive first-line anti-myeloma treatment as standard of care. Patients will continue to receive Denosumab or zoledronic acid (depending on treatment arm) until approximately 800 subjects have at least one on study skeletal related event and the primary efficacy and safety analysis is completed. If Denosumab is determined to have a positive benefit to risk profile compared with Zoledronic acid, all subjects still receiving treatment will be offered open label Denosumab at a dose of 120mg SC for up to 2 years. If the benefit to risk profile is not positive, all patients will be followed for survival for 2 years. Patients' disease status will be evaluated every 4 weeks by blood, serum or urine assessments until confirmed best reponse, then every 8 weeks until first disease progression.
REC name
London - South East Research Ethics Committee
REC reference
12/LO/1076
Date of REC Opinion
8 Oct 2012
REC opinion
Further Information Favourable Opinion