Denosumab (Xgeva) was non-inferior to zoledronic acid in delaying the time to skeletal-related events in patients with newly diagnosed multiple myeloma, according to a press release.1

To compare the efficacy of denosumab in delaying bone complications with that of zoledronic acid, the international, double-blind, phase 3 ‘482 study ( Identifier: NCT01345019) randomly assigned 1718 newly diagnosed patients with multiple myeloma to receive subcutaneous denosumab and intravenous placebo every 4 weeks, or intravenous zoledronic acid and subcutaneous placebo every 4 weeks.

Preliminary results showed no significant difference in the time to skeletal-related events between the 2 treatment arms (hazard ratio, 0.98; 95% CI, 0.85-1.14; P = .01). Median time to the first on-study skeletal-related event was 22.83 months with denosumab vs 23.98 months with zoledronic acid.

Continue Reading

The study failed to demonstrate superiority with denosumab in delaying time to the first skeletal-related event and delaying time to the first-and-subsequent skeletal-related events.

RELATED: Bendamustine-triplet in Front-line Multiple Myeloma

Denosumab treatment appeared to reduce the risk of progression or death by 18% (hazard ratio, 0.82; 95% CI, 0.68-0.99; P = .036), but there was no significant difference in overall survival between the 2 groups. The most common adverse events in the denosumab arm were diarrhea and nausea.

Amgen plans to submit these new data to the U.S. Food and Drug Administration to support a potential update to the prescribing information of denosumab.


  1. Amgen presents new data from phase 3 Xgeva (denosumab) study in multiple myeloma patients at the 16th International Myeloma Workshop [news release]. Thousand Oaks, CA: Amgen; March 3, 2017. Accessed March 6, 2017.