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After 18 cycles, dexamethasone was discontinued and treatment was continued using reduced-dose ixazomib (3 mg) and lenalidomide (10 mg) until progression\/toxicity. The primary endpoint was progression-free survival (PFS). Median PFS was 35.3 vs 21.8 months with ixazomib-Rd vs placebo-Rd, respectively (hazard ratio [HR], 0.830; 95% confidence interval, 0.676-1.018; P = .073; median follow-up, 53.3 and 55.8 months). Complete (26% vs 14%; odds ratio [OR], 2.10; P &amp;lt; .001) and \u2265 very good partial response (63% vs 48%; OR, 1.87; P &amp;lt; .001) rates were higher with ixazomib-Rd vs placebo-Rd. In a prespecified high-risk cytogenetics subgroup, median PFS was 23.8 vs 18.0 months (HR, 0.690; P = .019). Overall, treatment-emergent adverse events (TEAEs) were mostly grade 1\/2. With ixazomib-Rd vs placebo-Rd, 88% vs 81% of patients experienced grade \u22653 TEAEs, 66% vs 62% serious TEAEs, and 35% vs 27% TEAEs resulting in regimen discontinuation; 8% vs 6% died on study. Addition of ixazomib to Rd was tolerable with no new safety signals and led to a clinically meaningful PFS benefit of 13.5 months. Ixazomib-Rd is a feasible option for certain patients who can benefit from an all-oral triplet combination. This trial was registered at www.clinicaltrials.gov as #NCT01850524.<\/jats:p>","DOI":"10.1182\/blood.2020008787","type":"journal-article","created":{"date-parts":[[2021,3,24]],"date-time":"2021-03-24T20:55:57Z","timestamp":1616619357000},"page":"3616-3628","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":99,"title":["Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma"],"prefix":"10.1182","volume":"137","author":[{"given":"Thierry","family":"Facon","sequence":"first","affiliation":[{"name":"Centre Hospitalier Universitaire (CHU) Lille, Service des Maladies du Sang, University of Lille, Lille, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher P.","family":"Venner","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, 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