Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- overall Survival
研究概览
简要总结
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.
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
- Double
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.
排除标准
- •Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
- •Primary or associated amyloïdosis
- •World Health organisation performance index of at least 3
- •Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
- •Cardiac or hepatic dysfunction
- •Cerebral circulatory insufficiency
- •Absolute contraindication to corticosteroids
- •Peripheral neuropathy clinically significant
- •History of venous thrombosis during the last 6 months
- •HIV or hepatitis B or C positivity
- •Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.
研究组 & 干预措施
A
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
干预措施: Thalidomide (Drug)
A
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
干预措施: melphalan, prednisone (Drug)
B
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
干预措施: melphalan, prednisone, thalidomide (Drug)
结局指标
主要结局
overall Survival
时间窗: May 2007
次要结局
- Progression Free Survival(May 2007)
- Response rates(May 2007)
- Safety(May 2007)