{"entity":{"id":"paper-aquila-daratumumab-smouldering-nejm-2025","kind":"paper","name":"AQUILA: daratumumab versus active monitoring in high-risk smouldering multiple myeloma","aka":[],"tldr":"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.","summary":"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.\n\nFive-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.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2025","url":"https://doi.org/10.1056/NEJMoa2409029"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39652675/"}],"tags":[],"related":[],"cancers":["smouldering-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["daratumumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["aquila"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2025,"doi":"10.1056/NEJMoa2409029","pmid":"39652675","authors":"Dimopoulos MA, Voorhees PM, Schjesvold F, et al.","paperType":"rct","findings":["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."],"whatItMeans":"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.","caveats":["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."],"changedPractice":true,"participants":390},"route":"/key-papers/paper-aquila-daratumumab-smouldering-nejm-2025/","neighbours":{"cancer":[{"id":"smouldering-myeloma","kind":"cancer","name":"Smouldering multiple myeloma","route":"/cancers/smouldering-myeloma/"}],"drug":[{"id":"daratumumab","kind":"drug","name":"Daratumumab","route":"/drugs/daratumumab/"}],"trial":[{"id":"aquila","kind":"trial","name":"AQUILA","route":"/trials/aquila/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}