NCT02577783Unknown4 期
Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed and untreated multiple myeloma patients
- •Patients with age between 18 and 70 years
- •With a evaluable disease
- •ECOG score ≤2
- •NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L
- •AST, ALT, ALP≤3×ULN, serum BIL≤ULN
- •LVEF≥ 50%
- •Not in pregnancy
- •Written informed consent are acquired
排除标准
- •Severe heart failure (NYHA grade II or higher)
- •Active and uncontrolled severe infection
- •HIV positive
- •Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin
- •Grade 2 or higher peripheral neuropathy before treatment
- •Have suffered any other malignancy in past 5 years
- •Females in lactation
- •Other situations that investigators consider as contra-indication for this study
结局指标
主要结局
Response rate
时间窗: 4 cycles (each cycle is 28 days) of chemotherapy
sCR + CR + VGPR
次要结局
- Overall remission rate(4 cycles (each cycle is 28 days) of chemotherapy)
- Progression-free survival(3 year)
- Adverse Event(3 year)
研究者
研究点 (1)
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