- In a phase 3 study of patients with newly diagnosed multiple myeloma, denosumab was noninferior to zoledronic acid (ZA) for preventing skeletal-related events (SREs).
Why this matters
- Denosumab also improved PFS and reduced adverse events (AEs) associated with renal toxicity.
- Phase 3, multicenter, double-blind, randomized, controlled trial of 1718 patients assigned to subcutaneous denosumab 120 mg + intravenous placebo every 4 weeks, or intravenous ZA 4 mg plus subcutaneous placebo every 4 weeks.
- Funding: Amgen.
- Denosumab was noninferior to ZA for time to first SRE (HR, 0.98; Pnoninferiority=.010).
- Median PFS was 46.1 months (95% CI, 34.3-NE [not estimable]) with denosumab vs 35.4 months (95% CI, 30.2-NE) with ZA (HR, 0.82; descriptive P=.036).
- The most common grade 3 or higher treatment-emergent adverse events with denosumab vs ZA were neutropenia (15% for both), thrombocytopenia (14% vs 12%), anemia (12% vs 10%), and febrile neutropenia (11% vs 10%).
- Renal toxicity affected 10% of denosumab-treated patients vs 17% of those receiving ZA; corresponding hypocalcemia rates were 17% and 12%, respectively.
- No response data were gathered.
- Exclusion of patients with creatinine clearance <30 mL/min.