{"entity":{"id":"aquila","kind":"trial","name":"AQUILA","aka":[],"tldr":"AQUILA showed that treating high-risk smouldering myeloma with the antibody daratumumab, rather than waiting for it to turn into active disease, delayed that progression, making it the first drug shown in a randomised trial to hold back myeloma before it causes symptoms.","summary":"AQUILA was an open-label phase 3 trial in patients with smouldering multiple myeloma judged high risk by disease burden and biomarkers. Patients were randomised to subcutaneous daratumumab monotherapy for up to 39 cycles or three years, or to active monitoring, the standard of care.\n\nDaratumumab significantly prolonged progression-free survival, defined as progression to active myeloma by SLiM-CRAB criteria or death, the primary endpoint. It was the first phase 3 trial of a monoclonal antibody in this precursor state and led to approval of daratumumab for high-risk smouldering myeloma in the United States in 2025. The earlier E3A06 trial had shown a similar effect with lenalidomide but without a survival benefit; how to define high risk well enough to justify treatment remains the live question.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03301220","url":"https://clinicaltrials.gov/study/NCT03301220"}],"tags":["subtype-trials"],"related":[],"cancers":["smouldering-myeloma","multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["daratumumab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["meletios-dimopoulos"],"bottlenecks":[],"keyPapers":["paper-aquila-daratumumab-smouldering-nejm-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03301220","phase":"3","setting":"High-risk smouldering multiple myeloma: subcutaneous daratumumab alone for up to three years against active monitoring","sponsor":"Janssen","result":"Subcutaneous daratumumab delayed progression to active myeloma or death compared with active monitoring in high-risk smouldering myeloma; approved in the United States in 2025.","yearReported":2024,"enrolled":390,"outcomes":[]},"route":"/trials/aquila/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"smouldering-myeloma","kind":"cancer","name":"Smouldering multiple myeloma","route":"/cancers/smouldering-myeloma/"}],"drug":[{"id":"daratumumab","kind":"drug","name":"Daratumumab","route":"/drugs/daratumumab/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"person":[{"id":"meletios-dimopoulos","kind":"person","name":"Meletios A. Dimopoulos","route":"/people/meletios-dimopoulos/"}],"paper":[{"id":"paper-aquila-daratumumab-smouldering-nejm-2025","kind":"paper","name":"AQUILA: daratumumab versus active monitoring in high-risk smouldering multiple myeloma","route":"/key-papers/paper-aquila-daratumumab-smouldering-nejm-2025/"}]}}