Pharmacokinetics and safety of ixazomib plus lenalidomide-dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study
DC Field | Value | Language |
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dc.contributor.author | Gupta, Neeraj | - |
dc.contributor.author | Goh, Yeow Tee | - |
dc.contributor.author | Min, Chang-Ki | - |
dc.contributor.author | Lee, Jae Hoon | - |
dc.contributor.author | Kim, Kihyun | - |
dc.contributor.author | Wong, Raymond S. M. | - |
dc.contributor.author | Chim, Chor Sang | - |
dc.contributor.author | Hanley, Michael J. | - |
dc.contributor.author | Yang, Huyuan | - |
dc.contributor.author | Venkatakrishnan, Karthik | - |
dc.contributor.author | Hui, Ai-Min | - |
dc.contributor.author | Esseltine, Dixie-Lee | - |
dc.contributor.author | Chng, Wee Joo | - |
dc.date.available | 2020-02-28T08:41:24Z | - |
dc.date.created | 2020-02-06 | - |
dc.date.issued | 2015-09-04 | - |
dc.identifier.issn | 1756-8722 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/10133 | - |
dc.description.abstract | Background: The oral proteasome inhibitor ixazomib is under phase 3 clinical investigation in multiple myeloma (MM) in combination with lenalidomide-dexamethasone. This study was conducted to investigate the pharmacokinetic and safety profiles of ixazomib, administered with lenalidomide-dexamethasone, in East Asian patients with relapsed/refractory MM. Methods: Adult patients with measurable disease who had received 1-3 prior lines of therapy received oral ixazomib on days 1, 8, and 15, lenalidomide (25 mg) on days 1-21, and dexamethasone (40 mg) on days 1, 8, 15, and 22, in 28-day cycles. Primary objectives were to characterize ixazomib plasma pharmacokinetics, determine the recommended phase 2/3 dose, and evaluate safety and tolerability. Results: Forty-three patients were enrolled. No dose-limiting toxicities were reported for the first six patients receiving ixazomib (4.0 mg), confirming this as the recommended phase 2/3 dose. Ixazomib was rapidly absorbed with a median Tmax of 1.5 h on day 1 and 2.0 h on day 15 of cycle 1 and had a geometric mean terminal half-life of 6.1 days. Twenty-one (49 %) patients had at least one drug-related grade >= 3 adverse event (AE); the most common were neutropenia (19 %), diarrhea (14 %), and thrombocytopenia (12 %). Twenty-eight of 43 (65 %) response-evaluable patients had at least a partial response. The recommended phase 2/3 dose for ixazomib was determined to be 4.0 mg. Conclusions: The all-oral combination of ixazomib plus lenalidomide-dexamethasone appeared active and well tolerated at 4.0 mg. Consequently, East Asian patients enrolled in phase 3 studies are receiving the same ixazomib dose as patients in other regions. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BMC | - |
dc.relation.isPartOf | JOURNAL OF HEMATOLOGY & ONCOLOGY | - |
dc.subject | ORAL PROTEASOME INHIBITOR | - |
dc.subject | BORTEZOMIB-THALIDOMIDE-DEXAMETHASONE | - |
dc.subject | STEM-CELL TRANSPLANTATION | - |
dc.subject | MULTIPLE-MYELOMA | - |
dc.subject | CONSOLIDATION THERAPY | - |
dc.subject | COMBINATION | - |
dc.subject | CARFILZOMIB | - |
dc.subject | ETHNICITY | - |
dc.subject | TRIAL | - |
dc.title | Pharmacokinetics and safety of ixazomib plus lenalidomide-dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 study | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000361364400001 | - |
dc.identifier.doi | 10.1186/s13045-015-0198-1 | - |
dc.identifier.bibliographicCitation | JOURNAL OF HEMATOLOGY & ONCOLOGY, v.8 | - |
dc.identifier.scopusid | 2-s2.0-84940658248 | - |
dc.citation.title | JOURNAL OF HEMATOLOGY & ONCOLOGY | - |
dc.citation.volume | 8 | - |
dc.contributor.affiliatedAuthor | Lee, Jae Hoon | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Multiple myeloma | - |
dc.subject.keywordAuthor | Ixazomib | - |
dc.subject.keywordAuthor | Ethnicity | - |
dc.subject.keywordAuthor | East Asian | - |
dc.subject.keywordAuthor | Pharmacokinetics | - |
dc.subject.keywordPlus | ORAL PROTEASOME INHIBITOR | - |
dc.subject.keywordPlus | BORTEZOMIB-THALIDOMIDE-DEXAMETHASONE | - |
dc.subject.keywordPlus | STEM-CELL TRANSPLANTATION | - |
dc.subject.keywordPlus | MULTIPLE-MYELOMA | - |
dc.subject.keywordPlus | CONSOLIDATION THERAPY | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | CARFILZOMIB | - |
dc.subject.keywordPlus | ETHNICITY | - |
dc.subject.keywordPlus | TRIAL | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Hematology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Hematology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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