{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T10:59:32Z","timestamp":1753354772455,"version":"3.40.5"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,3,7]],"date-time":"2020-03-07T00:00:00Z","timestamp":1583539200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Haematology"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>We evaluated ibrutinib, a once\u2010daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed\/refractory multiple myeloma who had received 1\u20103 prior therapies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a phase 2, single\u2010arm, open\u2010label, multicentre study (NCT02902965). The primary endpoint was progression\u2010free survival (PFS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventy\u2010six patients were enrolled; 74 received \u22651 dose of study treatment. After median follow\u2010up of 19.6\u00a0months, median PFS was 8.5\u00a0months (95% CI: 6.2\u201010.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45\u201068), and median duration of response was 9.5\u00a0months (95% CI: 6.9\u201010.6). Grade 3\/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, enrolment was suspended to implement risk\u2010minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Ibrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ejh.13377","type":"journal-article","created":{"date-parts":[[2019,12,28]],"date-time":"2019-12-28T17:54:32Z","timestamp":1577555672000},"page":"435-442","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed\/refractory multiple myeloma"],"prefix":"10.1111","volume":"104","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6955-6267","authenticated-orcid":false,"given":"Roman","family":"Hajek","sequence":"first","affiliation":[{"name":"University Hospital of Ostrava Ostrava\u2010Poruba\u2010Poruba Czech Republic"},{"name":"Faculty of Medicine University of Ostrava Ostrava Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ludek","family":"Pour","sequence":"additional","affiliation":[{"name":"University Hospital Brno Brno Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muhit","family":"Ozcan","sequence":"additional","affiliation":[{"name":"Ankara University School of Medicine Ankara Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jesus","family":"Martin S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen del Rocio Sevilla Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ramon","family":"Garc\u00eda Sanz","sequence":"additional","affiliation":[{"name":"University Hospital of Salamanca Salamanca Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Achilles","family":"Anagnostopoulos","sequence":"additional","affiliation":[{"name":"General Hospital of Thessaloniki \u201cG. Papanikolaou,\" Thessaloniki Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albert","family":"Oriol","sequence":"additional","affiliation":[{"name":"Institut Catal\u00e0 d\u2019Oncologia and Institut Josep Carreras Hospital Germans Trias i Pujol Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Cascavilla","sequence":"additional","affiliation":[{"name":"IRCCS \u201cCasa Sollievo della Sofferenza\u201d Hospital San Giovanni Rotondo Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Terjung","sequence":"additional","affiliation":[{"name":"Pharmacyclics Switzerland GmbH an AbbVie Company Schaffhausen Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yihua","family":"Lee","sequence":"additional","affiliation":[{"name":"Pharmacyclics LLC an AbbVie Company Sunnyvale CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eva M.","family":"Briso","sequence":"additional","affiliation":[{"name":"Pharmacyclics Switzerland GmbH an AbbVie Company Schaffhausen Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edyta","family":"Dobkowska","sequence":"additional","affiliation":[{"name":"Pharmacyclics Switzerland GmbH an AbbVie Company Schaffhausen Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernhard","family":"Hauns","sequence":"additional","affiliation":[{"name":"Pharmacyclics Switzerland GmbH an AbbVie Company Schaffhausen Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ivan","family":"\u0160pi\u010dka","sequence":"additional","affiliation":[{"name":"1st Department of Medicine \u2010 Department of Hematology First Faculty of Medicine Charles University and General Hospital in Prague Prague Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,3,7]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2017.46"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21442"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0841-y"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-12-396853"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-14-2362"},{"key":"e_1_2_9_7_1","unstructured":"Janssen\u2010Cilag International NV.IMBRUVICA (ibrutinib) Summary of Product Characteristics 2018. 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