Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia (Bortezomib)
Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).
The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).
Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国
- 招聘中
- Beijing Clinical Service Center
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接触：
- zhao wang, M.D
- 电话号码：861063138303 861063138303
- 邮箱：zhaowww263@yahoo.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib
- KPS ≥ 60
- Adequate liver and renal function within 2 weeks of Screening:
- Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
- Cardiac function > Ⅲ grade and ejection fraction > 45%
- Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care
Exclusion Criteria:
- has taken Bortezomib
- KPS ≤ 60 scores
- mental illness
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：V-DD single arm
INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. |
INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
其他名称：
INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle.
6 Cycles: until progression or unacceptable toxicity develops.
其他名称：
INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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overall response rate
大体时间：Day 1 of every treatment cycle
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The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria
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Day 1 of every treatment cycle
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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the rate of response
大体时间：Day 1 of every treatment cycle
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The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
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Day 1 of every treatment cycle
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partial remission rate
大体时间：Day 1 of every treatment cycle
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The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
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Day 1 of every treatment cycle
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duration of response
大体时间：up to 6 months
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up to 6 months
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overall survival
大体时间：up to two and a half year
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up to two and a half year
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Adverse Events
大体时间：up to two and a half years
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Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
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up to two and a half years
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FACT/GOC-Ntx
大体时间：Day 1 of every treatment cycle
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Day 1 of every treatment cycle
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合作者和调查者
合作者
调查人员
- 首席研究员：zhao wang, Master、Beijing Friendship Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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