dc.contributor.author | Kaiser, M | |
dc.contributor.author | Beksaç, M | |
dc.contributor.author | Gulbrandsen, N | |
dc.contributor.author | Schjesvold, F | |
dc.contributor.author | Hájek, R | |
dc.contributor.author | Moreau, P | |
dc.contributor.author | de Arriba de la Fuente, F | |
dc.contributor.author | Mateos, M-V | |
dc.contributor.author | West, S | |
dc.contributor.author | Spencer, A | |
dc.contributor.author | Rajkumar, SV | |
dc.contributor.author | Suryanarayan, K | |
dc.contributor.author | Czorniak, M | |
dc.contributor.author | Li, C | |
dc.contributor.author | Teng, Z | |
dc.contributor.author | Labotka, R | |
dc.contributor.author | Dimopoulos, MA | |
dc.date.accessioned | 2020-08-26T14:26:49Z | |
dc.date.issued | 2020-08-01 | |
dc.identifier.citation | Annals of hematology, 2020, 99 (8), pp. 1793 - 1804 | |
dc.identifier.issn | 0939-5555 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4018 | |
dc.identifier.eissn | 1432-0584 | |
dc.identifier.doi | 10.1007/s00277-020-04149-5 | |
dc.description.abstract | 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 = 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.format | Print-Electronic | |
dc.format.extent | 1793 - 1804 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | SPRINGER | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Multiple Myeloma | |
dc.subject | Boron Compounds | |
dc.subject | Silicates | |
dc.subject | Glycine | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Disease-Free Survival | |
dc.subject | Stem Cell Transplantation | |
dc.subject | Survival Rate | |
dc.subject | Follow-Up Studies | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Autografts | |
dc.title | Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-06-14 | |
rioxxterms.versionofrecord | 10.1007/s00277-020-04149-5 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2020-08 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Annals of hematology | |
pubs.issue | 8 | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 99 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Myeloma Group | |
dc.contributor.icrauthor | Kaiser, Martin | |