Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

Status Completed

Clinical Trial Summary

Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Clinical Trial Description

This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis. ;

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Amyloidosis

Clinical Trial Details

NCT number	NCT02485613
Study type	Observational
Source	Nanjing University School of Medicine
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	March 2015

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