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

INTERVENTION: Intervention name : Denosumab INN of the intervention : Denosumab Dosage And administration of the intervention : Denosumab 120 mg subcutaneous injection every 4 weeks Control intervention name : Zoledronic Acid INN of the control intervention : Zoledronic Acid Dosage And administration of the control intervention : Zoledronic acid 4 mg (adjusted for renal function) Intravenous infusion over at least 15 minutes every 4 weeks CONDITION: Multiple Myeloma PRIMARY OUTCOME: Time to the first on‐study SRE SECONDARY OUTCOME: Time to the first‐and‐subsequent on‐study SRE INCLUSION CRITERIA: ‐Adults with newly diagnosed multiple myeloma ‐Radiographic evidence of at least 1 bone lesion ‐Plan to receive primary frontline anti‐myeloma therapies ‐Adequate organ function ‐Written informed consent