Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone) followed by autologous hematopoietic stem cell transplantation as an initial treatment in patients with newly diagnosed AL.
详细描述
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4. After two cycles of vel / dex therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4 weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the cycle) will be conducted as consolidation therapy during the recommended 60-90 days after HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and platelet count> 50x109/L). Later patients won't need maintenance therapy.
The efficacy criteria are the international standards set with consensus of experts in the Tenth International Symposium on Amyloid and Amyloidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female;
- •aged 18-65 years;
- •Patients with newly diagnosed AL;
- •Appropriate for autologous hematopoietic stem cell transplantation;
- •Abnormal M protein or free light chain detected in serum and / or urine
- •ECOG score 0-2 points;
- •Subjects (or their legal representatives) must signed an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
排除标准
- •Subjects received systematic treatment with steroids
- •Subjects received plasmapheresis to treat clinical significant hyperviscosity syndrome within 4 weeks before enrollment.
- •Pregnant and breastfeeding women;
- •Subjects suffering from multiple myeloma.
- •hypersensitivity to dexamethasone, bortezomib, mannitol, boron, or heparin (if use catheters);
- •Subjects have severe cardiovascular disease,
- •Subjects have serious physical disease and mental illnesses which may interfere the study
研究组 & 干预措施
Bortezomib
Patients will receive two 21-day cycles of induction therapy with vel / dex regimen. Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while Dexamethasone 40 mg/d will be taken orally on days 1-4.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Complete response rate
时间窗: 12 months
Complete response rate at 12 months post-transplantation
次要结局
- overall response rate(12 months)
研究者
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine