{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:25:52Z","timestamp":1790814352733,"version":"4.1.0"},"reference-count":28,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2020,4,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>One hundred eighty-two patients were randomly assigned\u201492 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; P = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.19.01740","type":"journal-article","created":{"date-parts":[[2019,10,25]],"date-time":"2019-10-25T15:59:12Z","timestamp":1572019152000},"page":"1126-1137","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":267,"title":["Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma"],"prefix":"10.1200","volume":"38","author":[{"given":"Sagar","family":"Lonial","sequence":"first","affiliation":[{"name":"Emory University, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanna","family":"Jacobus","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Fonseca","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Scottsdale, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Weiss","sequence":"additional","affiliation":[{"name":"ThedaCare Cancer Center, Appleton, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaji","family":"Kumar","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert Z.","family":"Orlowski","sequence":"additional","affiliation":[{"name":"MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan L.","family":"Kaufman","sequence":"additional","affiliation":[{"name":"Emory University, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abdulraheem M.","family":"Yacoub","sequence":"additional","affiliation":[{"name":"University of Kansas Cancer Center, Westwood, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis K.","family":"Buadi","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"O\u2019Brien","sequence":"additional","affiliation":[{"name":"MetroHealth Medical Center, Cleveland, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey V.","family":"Matous","sequence":"additional","affiliation":[{"name":"Colorado Blood Cancer Institute and Sarah Cannon Research Institute, Denver, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel M.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Park Nicollet Clinic, Saint Louis Park, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert V.","family":"Emmons","sequence":"additional","affiliation":[{"name":"University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuj","family":"Mahindra","sequence":"additional","affiliation":[{"name":"Scripps Clinic Torrey Pines, La Jolla, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne I.","family":"Wagner","sequence":"additional","affiliation":[{"name":"Wake Forest University Health Sciences, Winston-Salem, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madhav V.","family":"Dhodapkar","sequence":"additional","affiliation":[{"name":"Emory University, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. 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