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dc.contributor.authorKaiser, M
dc.contributor.authorBeksaç, M
dc.contributor.authorGulbrandsen, N
dc.contributor.authorSchjesvold, F
dc.contributor.authorHájek, R
dc.contributor.authorMoreau, P
dc.contributor.authorde Arriba de la Fuente, F
dc.contributor.authorMateos, M-V
dc.contributor.authorWest, S
dc.contributor.authorSpencer, A
dc.contributor.authorRajkumar, SV
dc.contributor.authorSuryanarayan, K
dc.contributor.authorCzorniak, M
dc.contributor.authorLi, C
dc.contributor.authorTeng, Z
dc.contributor.authorLabotka, R
dc.contributor.authorDimopoulos, MA
dc.date.accessioned2020-08-26T14:26:49Z
dc.date.issued2020-08
dc.identifier.citationAnnals of hematology, 2020, 99 (8), pp. 1793 - 1804
dc.identifier.issn0939-5555
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4018
dc.identifier.eissn1432-0584
dc.identifier.doi10.1007/s00277-020-04149-5
dc.description.abstractThe 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 = 395) or placebo (n = 261) on days 1, 8, and 15 of 28-day cycles for ~ 2 years or until progressive disease/toxicity. The initial 3-mg ixazomib dose was escalated to 4 mg in cycle 5, if tolerated in cycles 1-4. 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 ≥ 3 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.
dc.formatPrint-Electronic
dc.format.extent1793 - 1804
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectMultiple Myeloma
dc.subjectBoron Compounds
dc.subjectSilicates
dc.subjectGlycine
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectDisease-Free Survival
dc.subjectStem Cell Transplantation
dc.subjectSurvival Rate
dc.subjectFollow-Up Studies
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectAutografts
dc.titleAdverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma.
dc.typeJournal Article
dcterms.dateAccepted2020-06-14
rioxxterms.versionofrecord10.1007/s00277-020-04149-5
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2020-08
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfAnnals of hematology
pubs.issue8
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Myeloma Group
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Myeloma Group
pubs.publication-statusPublished
pubs.volume99en_US
pubs.embargo.termsNot known
icr.researchteamMyeloma Groupen_US
dc.contributor.icrauthorKaiser, Martinen


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