Scheid, Christof, Reece, Donna, Beksac, Meral, Spencer, Andrew, Callander, Natalie ORCID: 0000-0002-6975-1086, Sonneveld, Pieter, Kalimi, Ghulam, Cai, Can, Shi, Michael, Scott, Jeffrey W. and Stewart, A. Keith (2015). Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation. Eur. J. Haematol., 95 (4). S. 316 - 325. HOBOKEN: WILEY. ISSN 1600-0609

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Abstract

ObjectivesApproximately 15% of patients with multiple myeloma (MM) exhibit a t(4;14) translocation, which often results in constitutive activation of the receptor tyrosine kinase (RTK) fibroblast growth factor receptor 3 (FGFR3). This study evaluated the efficacy and safety of dovitinib, an RTK inhibitor with in vitro inhibitory activity against FGFR, in patients with relapsed or refractory MM with or without t(4;14) translocation. MethodsAdult patients with relapsed or refractory MM who had received 2 prior regimens were enrolled in this multicenter, 2-stage, phase 2 trial. Patients were grouped based on their t(4;14) status. Dovitinib (500mg/day orally) was administered on a 5-days-on/2-days-off schedule. The primary endpoint was overall response rate by local investigator review (per International Myeloma Working Group criteria). In non-responding patients, treatment could continue with the addition of low-dose dexamethasone. ResultsIn total, 43 patients (median age, 63years) were enrolled (13 t(4;14) positive, 26 t(4;14) negative, and 4 t(4;14) status non-interpretable). Patients had received a median of 5 prior regimens. Median duration of treatment was 8.7weeks in the t(4;14)-positive group and 3.7weeks in the t(4;14)-negative group. None of the patients on dovitinib had objective responses. The stable disease rate was 61.5% in the t(4;14)-positive group and 34.6% in the t(4;14)-negative group. Overall, 39 patients (90.7%) had adverse events suspected to be related to study drug, most commonly diarrhea (60.5%), nausea (58.1%), vomiting (46.5%), and fatigue (32.6%). ConclusionDovitinib showed no single-agent activity in relapsed or refractory MM but may stabilize disease in some t(4;14)-positive patients.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Scheid, ChristofUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reece, DonnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beksac, MeralUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spencer, AndrewUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Callander, NatalieUNSPECIFIEDorcid.org/0000-0002-6975-1086UNSPECIFIED
Sonneveld, PieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalimi, GhulamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cai, CanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shi, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scott, Jeffrey W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stewart, A. KeithUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-391759
DOI: 10.1111/ejh.12491
Journal or Publication Title: Eur. J. Haematol.
Volume: 95
Number: 4
Page Range: S. 316 - 325
Date: 2015
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1600-0609
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
GROWTH-FACTOR RECEPTOR-3; KINASE INHIBITOR; STAT ACTIVATION; FGFR3; IDENTIFICATION; CHIR-258; EXPRESSION; PROGNOSIS; THERAPY; PATHWAYMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/39175

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