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Ibrutinib is a first\u2010in\u2010class, once\u2010daily, oral covalent inhibitor of Bruton tyrosine kinase, which is overexpressed in the myeloma stem cell population. This study examined various doses of ibrutinib\u00a0\u00b1\u00a0low\u2010dose dexamethasone in patients who received \u22652 prior lines of therapy, including an immunomodulatory agent. Daily ibrutinib\u00a0\u00b1\u00a0weekly dexamethasone 40\u00a0mg was assessed in 4 cohorts using a Simon 2\u2010stage design. The primary objective was clinical benefit rate (<jats:styled-content style=\"fixed-case\">CBR<\/jats:styled-content>; \u2265minimal response); secondary objectives included safety. Patients (<jats:italic>n\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>92) received a median of 4 prior regimens. Ibrutinib\u00a0+\u00a0dexamethasone produced the highest <jats:styled-content style=\"fixed-case\">CBR<\/jats:styled-content> (28%) in Cohort 4 (840\u00a0mg\u00a0+\u00a0dexamethasone; <jats:italic>n\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>43), with median duration of 9\u00b72\u00a0months (range, 3\u00b70\u201314\u00b77). Progression\u2010free survival was 4\u00b76\u00a0months (range, 0\u00b74\u201317\u00b73). Grade 3\u20134 haematological adverse events included anaemia (16%), thrombocytopenia (11%), and neutropenia (2%); grade 3\u20134 non\u2010haematological adverse events included pneumonia (7%), syncope (3%) and urinary tract infection (3%). Ibrutinib\u00a0+\u00a0dexamethasone produced notable responses in this heavily pre\u2010treated population. The encouraging efficacy, coupled with the favourable safety and tolerability profile of ibrutinib, supports its further evaluation as part of combination treatment.<\/jats:p>","DOI":"10.1111\/bjh.15058","type":"journal-article","created":{"date-parts":[[2018,2,13]],"date-time":"2018-02-13T07:18:44Z","timestamp":1518506324000},"page":"821-830","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results"],"prefix":"10.1111","volume":"180","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7426-8865","authenticated-orcid":false,"given":"Paul G.","family":"Richardson","sequence":"first","affiliation":[{"name":"Department of Medical Oncology Dana\u2010Farber Cancer Institute Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William 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