Why carry out this study?

Multiple myeloma (MM) is characterized by development of osteolytic lesions, which result from deregulation of normal bone remodeling, causing cancer-induced bone loss and destruction, and increased risk for fracture

The primary analysis of a global phase 3 study (NCT01345019) indicated that denosumab was noninferior to zoledronic acid for time to skeletal-related events (SREs) in patients with newly diagnosed MM with at least one lytic bone lesion; here we present a subgroup analysis of this study to evaluate efficacy and safety in patients from Asian countries

What was learned from this study?

Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group, results that are consistent with those from the full study

Rates of adverse events, including adjudicated osteonecrosis of the jaw and hypocalcemia, were generally similar between the two treatment groups, renal toxicity was less frequent in the denosumab than in the zoledronic acid group, and overall safety results for the Asian subgroup were in line with those from the full study

Efficacy and safety outcomes for denosumab and zoledronic acid from this Asian subgroup analysis of patients with MM were comparable to those from the primary analysis of the full study population, supporting the use of denosumab as an additional treatment option for the standard of care for Asian patients with newly diagnosed MM with osteolytic lesions