Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

Inclusion Criteria: * Documented evidence of multiple myeloma (per local assessment): * Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma, and * Monoclonal protein present in the serum and/or urine * Radiographic (X-ray, or computer tomography \[CT\]) evidence of at least 1 lytic bone lesion (or at least 1 focal lesion per magnetic resonance imaging \[MRI\]) * Plan to receive or is receiving primary frontline anti-myeloma therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Age ≥ 18 years * Adequate organ function, as defined by the following criteria (per central or local laboratory values): * Serum aspartate aminotransferase (AST) ≤ 2.0 x upper limit of normal (ULN) * Serum alanine aminotransferase ≤ (ALT) 2.0 x ULN * Serum total bilirubin ≤ 2.0 x ULN * Creatinine clearance ≥ 30 mL/min * Serum calcium or albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL) * Written informed consent before any study-specific procedure is performed Exclusion Criteria: * Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Plasma cell leukemia * More than 30 days of previous treatment (before screening) with anti-myeloma thera…