AQUILA: daratumumab versus active monitoring in high-risk smouldering multiple myeloma
Giving daratumumab for up to three years to people with high-risk smouldering myeloma roughly halved the risk of progressing to active myeloma or death compared with watching and waiting.
Overview
Phase 3 trial of 390 patients with high-risk smouldering multiple myeloma randomised to subcutaneous daratumumab monotherapy for up to 36 months or active monitoring.
Five-year progression-free survival was 63.1 percent with daratumumab against 40.8 percent with monitoring (hazard ratio 0.49), with a favourable trend in overall survival and a manageable toxicity profile.
- Five-year progression-free survival 63.1 percent vs 40.8 percent; hazard ratio 0.49.
- Five-year overall survival 93.0 percent vs 86.9 percent.
Early single-agent treatment of high-risk smouldering myeloma is now an option with regulatory approval, though monitoring remains acceptable and the definition of high risk matters.
- Risk definitions at enrolment predate the 20/2/20 model, so some patients were lower risk than intended.
- Whether early treatment improves survival compared with treating at progression remains unproven.
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