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.
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 Type
OBSERVATIONAL
Enrollment
72
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 dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.
Hematologic response rate
Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis
Time frame: 3 months
organ response rate
organ responses were evaluated according to the novel criteria of the International Society of Amyloidosis
Time frame: 12 months
Overall survival
Time frame: From date of the start of treatment to date of death,up to 3 months
Progression free survival
Time frame: From date of the start of treatment to date of disease progression,up to 3 months
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