{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T00:07:40Z","timestamp":1767139660449,"version":"build-2238731810"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T00:00:00Z","timestamp":1593561600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T00:00:00Z","timestamp":1593561600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Hematol"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study (NCT02181413) demonstrated improved progression-free survival with ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT) in multiple myeloma patients. We report additional safety data from TOURMALINE-MM3 to inform adverse event (AE) management recommendations. Patients were randomized 3:2 to receive ixazomib (\n                    <jats:italic>n\u2009=<\/jats:italic>\n                    \u00a0395) or placebo (\n                    <jats:italic>n\u2009=<\/jats:italic>\n                    \u00a0261) on days 1, 8, and 15 of 28-day cycles for ~\u20092\u00a0years or until progressive disease\/toxicity. The initial 3-mg ixazomib dose was escalated to 4\u00a0mg in cycle 5, if tolerated in cycles 1\u20134. Safety was a secondary endpoint assessed in all treated patients; AEs were graded using Common Terminology Criteria for AEs v4.03. The rate of grade \u2265\u20093 AEs was higher in the ixazomib arm (19%) than in the placebo arm (5%), but the rate of discontinuation due to AEs was similar (7% vs. 5%). For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%. However, the majority of events were low-grade, manageable with supportive therapy or dose reduction, and reversible, and did not result in discontinuation. There was no evidence of cumulative, long-term, or late-onset toxicity with ixazomib maintenance. Ixazomib is an efficacious and tolerable option for post-ASCT maintenance. AEs associated with ixazomib maintenance can be managed in the context of routine post-ASCT supportive care due to the limited additional toxicity. ClinicalTrials.gov NCT02181413\n                  <\/jats:p>","DOI":"10.1007\/s00277-020-04149-5","type":"journal-article","created":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T03:53:04Z","timestamp":1593575584000},"page":"1793-1804","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma"],"prefix":"10.1007","volume":"99","author":[{"given":"Martin","family":"Kaiser","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meral","family":"Beksa\u00e7","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina","family":"Gulbrandsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fredrik","family":"Schjesvold","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roman","family":"H\u00e1jek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Moreau","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felipe","family":"de Arriba de la Fuente","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda-Victoria","family":"Mateos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon","family":"West","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Spencer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. 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research funding from Celgene and Janssen; honoraria from Celgene, Janssen, Amgen, and TakedaMB: consulting\/advisory relationship with Amgen, Takeda, Bristol Myers Squib, Janssen & Janssen, and Sanofi, and honoraria received indirectly through the institutions for these consultancies; scientific advisory boards with Amgen, Takeda, BMS, Janssen & Janssen, and SanofiNG: nothing to discloseFS: consulting\/advisory relationship with Mundipharma, GSK, Pfizer\/BMS, Novartis, Amgen, Celgene, Takeda, Bayer, Adaptive, Janssen, Oncopeptides, and MSD, Sanofi; research funding from Celgene, Mundipharma, Amgen, Novartis, Takeda, and Janssen; honoraria from Amgen, Mundipharma, Celgene, Teva, BMS, Takeda, Abbvie, Janssen, Novartis, and SkyliteDX; ownership interests with OncopeptidesRH: consulting\/advisory relationship with Janssen, Amgen, Celgene, Abbvie, BMS, Novartis, Pharma Mar, and Takeda; research funding from Janssen, Amgen, Celgene, Abbvie, BMS, Novartis, and Takeda; honoraria from Janssen, Amgen, Celgene, Abbvie, BMS, Novartis, Pharma Mar, and TakedaPM: consulting\/advisory relationship with Takeda, Amgen, Celgene, Janssen, and Abbvie; honoraria from Takeda, Amgen, Celgene, Janssen, and AbbvieFdA: honoraria from Celgene, Amgen, Janssen, and Takeda; scientific advisory board with Celgene, Amgen, and JanssenM-VM: honoraria from Janssen, Celgene, Amgen, Takeda, Abbvie, GSK, Adaptive, EDO Mundipharma, Roche, and Seattle Genetics; scientific advisory board with Janssen, Celgene, Amgen, Takeda, Abbvie, GSK, Adaptive, EDO Mundipharma, Roche, and Seattle GeneticsSW: nothing to discloseAS: nothing to discloseSVR: nothing to discloseKS: employee of Millennium Pharmaceuticals Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company LimitedMC: employee of Millennium Pharmaceuticals Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company LimitedCL: employee of and ownership interests in Millennium Pharmaceuticals Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company LimitedZT: employee of Millennium Pharmaceuticals Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company LimitedRL: employee of Millennium Pharmaceuticals Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company LimitedMAD: honoraria from Amgen, Janssen, Takeda, Celgene, and BMS; consulting or advisory role with Amgen, Janssen, Takeda, Celgene, and BMS","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"TOURMALINE-MM3 was conducted in accordance with the International Conference on Harmonisation Guidelines for Good Clinical Practice and all relevant regulatory requirements. The protocol was approved by an ethics committee\/institutional review board at each center.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all patients for being included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors provided informed consent to publish.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}