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In this context, we assessed the efficacy of daratumumab in combination with ixazomib and dexamethasone (Dara\u2010Ixa\u2010dex) in the prospective phase 2 study DARIA. Eligible patients had relapsed\/refractory MM (RRMM) after one prior line with a lenalidomide\u2010based regimen. The primary endpoint was overall response rate (ORR). Secondary endpoints included survival outcomes, safety and changes in biomarkers of bone metabolism. Overall, 50 patients were enrolled (median age 69\u2009years, 56% males). 32 (64%) patients were refractory to lenalidomide, and 17 (34%) had undergone autologous transplant. The ORR was 64% (<jats:italic>n<\/jats:italic>\u2009=\u200932); whereas 17 (34%) had a very good partial response or better. The median time to first response was 1.0\u2009month. After a median follow\u2010up of 23.4\u2009months, the median PFS and OS were 8.1 and 39.2\u2009months, respectively. Furthermore, significant changes in markers of bone metabolism became evident as early as at 6\u2009months on treatment. Regarding safety, 21 (42%) patients had \u22651 grade 3\/4 adverse event (AE); the most common was thrombocytopenia (<jats:italic>n<\/jats:italic>\u2009=\u20099, 18%). 14 (28%) patients had \u22651 serious AE (SAE), the most common being acute kidney injury and pneumonia (<jats:italic>n<\/jats:italic>\u2009=\u20092, each). Four patients died due to infections. In conclusion, second\u2010line treatment with Dara\u2010Ixa\u2010dex in patients with RRMM pre\u2010treated with a lenalidomide\u2010based regimen resulted in rapid responses along with a favorable effect on bone metabolism.<\/jats:p>","DOI":"10.1002\/ajh.27206","type":"journal-article","created":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T07:28:05Z","timestamp":1706772485000},"page":"396-407","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Efficacy and safety of daratumumab with ixazomib and dexamethasone in lenalidomide\u2010exposed patients after one prior line of therapy: Final results of the phase 2 study <scp>DARIA<\/scp>"],"prefix":"10.1002","volume":"99","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5133-1422","authenticated-orcid":false,"given":"Evangelos","family":"Terpos","sequence":"first","affiliation":[{"name":"Department of Clinical Therapeutics National and Kapodistrian University of 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