NCT00222053已完成3 期
IFM 99-02 Thalidomide in Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Duration of response
研究概览
简要总结
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •de novo myeloma
- •according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
- •patients from 18 to 65 years old
- •beta2microglobulin < 3 mg/l or del13 absent
- •signed informed consent
- •eligible for transplantation
排除标准
- •peripheral neurological toxicities
- •uncontrolled or severe cardiovascular disease
- •other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
- •patient who received biphosphonate during the last 60 days
- •renal failure definited as creatinine > 150 µmol/l
- •patient with obvious vascular cerebral medical history
- •liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
- •respiratory dysfunction
- •Patient who refused to use an acceptable barrier method for contraception
研究组 & 干预措施
2
Active Comparator
Biphosphonates
干预措施: Biphosphonates (Drug)
3
Experimental
Thalidomide
干预措施: Thalidomide (Drug)
结局指标
主要结局
Duration of response
时间窗: 3 years
次要结局
- Survival(3 years)
- Toxicity(3 years)
研究者
研究点 (5)
Loading locations...
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