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Bortezomib in combination with dexamethasone for the treatment of patients with relapsed and/or refractory multiple myeloma with less than optimal response to bortezomib alone.

Abstract：

BACKGROUND AND OBJECTIVES:The efficacy and safety of added dexamethasone were assessed in patients with relapsed and/or refractory multiple myeloma who had a suboptimal response to bortezomib alone. DESIGN AND METHODS:In two previously reported, open-label, multicenter phase 2 studies, bortezomib 1.0 or 1.3 mg/m2 was administered intravenously twice weekly for 2 weeks of a 3-week cycle for up to 8 cycles to patients who had failed either > or = 2 lines of therapy (SUMMIT, n=202) or first-line therapy (CREST, n=54). Patients with progressive disease after the first two cycles or stable disease after four cycles of bortezomib were eligible for addition of oral dexamethasone 20 mg on the day of and after each bortezomib dose. Responses were assessed by an Independent Review Committee using European Group for Blood and Marrow Transplantation criteria. RESULTS:Addition of dexamethasone to bortezomib was associated with improved responses in 13 of 74 evaluable patients (18%) in SUMMIT and 9 of 27 (33%) in CREST; eight of these 22 patients had been previously refractory to dexamethasone. There were 2 complete, 8 partial, and 12 minimal responses. Dexamethasone did not appear to alter the type or number of adverse events. Treatment-emergent adverse events reported in > or = 20% of patients receiving combination therapy were fatigue (25%), thrombocytopenia (24%), insomnia (21%), and nausea (20%). INTERPRETATION AND CONCLUSIONS:Addition of dexamethasone to bortezomib in patients with relapsed and/or refractory myeloma who had suboptimal responses to bortezomib alone was associated with improvement in responses without prohibitive toxicity.

journal_name

Haematologica

journal_title

Haematologica

authors

Jagannath S,Richardson PG,Barlogie B,Berenson JR,Singhal S,Irwin D,Srkalovic G,Schenkein DP,Esseltine DL,Anderson KC,SUMMIT\/CREST Investigators.

subject

Has Abstract

pub_date

2006-07-01 00:00:00

pages

929-34

issue

eissn

0390-6078

issn

1592-8721

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Bortezomib in combination with dexamethasone for the treatment of patients with relapsed and/or refractory multiple myeloma with less than optimal response to bortezomib alone.