Bortezomib With Dexamethasone as the First-line Treatment for Immunoglobulin Light Chain(AL) Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Hematologic response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients aged between 18 to 80 years
- •Renal or other type biopsy was used to diagnose AL amyloidosis
- •Understand and voluntarily sign an informed consent form
- •ECOG score 0-3 points
- •Adequate residual organ function
排除标准
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •Grade 3 sensory or grade 1 painful peripheral neuropathy
- •Known hypersensitivity to bortezomib, boron or mannitol
- •Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
- •Clinically overt multiple myeloma
- •Pregnant or nursing women.
研究组 & 干预措施
bortezominb and dexamethasone group
干预措施: bortezominb and dexamethasone (Drug)
结局指标
主要结局
Hematologic response rate
时间窗: 3 months
Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis
次要结局
- organ response rate(12 months)
- Overall survival(From date of the start of treatment to date of death,up to 3 months)
- Progression free survival(From date of the start of treatment to date of disease progression,up to 3 months)
研究者
Zhi-Hong Liu, M.D.
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing University School of Medicine