{"entity":{"id":"paper-e3a06-lenalidomide-smouldering-lonial-jco-2020","kind":"paper","name":"E3A06: lenalidomide versus observation in smouldering multiple myeloma","aka":[],"tldr":"Lenalidomide alone delayed progression to active myeloma in people with intermediate- or high-risk smouldering disease, but side effects led many to stop, and it did not improve survival.","summary":"Phase 2/3 trial randomising 182 patients with intermediate- or high-risk smouldering myeloma to lenalidomide 25 mg or observation.\n\nThree-year progression-free survival was 91 percent with lenalidomide against 66 percent with observation (hazard ratio 0.28), with the largest benefit in high-risk patients; about half of treated patients discontinued for toxicity.","asOf":"2026-09-17","links":[{"label":"J Clin Oncol 2020","url":"https://doi.org/10.1200/JCO.19.01740"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/31652094/"}],"tags":[],"related":[],"cancers":["smouldering-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":["lenalidomide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2020,"doi":"10.1200/JCO.19.01740","pmid":"31652094","authors":"Lonial S, Jacobus S, Fonseca R, et al.","paperType":"rct","findings":["Three-year progression-free survival 91 percent vs 66 percent; hazard ratio 0.28.","Grade 3 to 4 adverse events in 28 percent of the lenalidomide arm."],"whatItMeans":"Lenalidomide showed that intervening before symptoms can delay end-organ damage, supporting later trials such as AQUILA, but tolerability limits its use as a single agent.","caveats":["No overall survival benefit shown.","Progression was defined by end-organ damage, and imaging at baseline was not modern PET or MRI in all patients."],"changedPractice":true,"participants":182},"route":"/key-papers/paper-e3a06-lenalidomide-smouldering-lonial-jco-2020/","neighbours":{"cancer":[{"id":"smouldering-myeloma","kind":"cancer","name":"Smouldering multiple myeloma","route":"/cancers/smouldering-myeloma/"}],"drug":[{"id":"lenalidomide","kind":"drug","name":"Lenalidomide","route":"/drugs/lenalidomide/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}