Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 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 used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.
详细描述
Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.
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
- 65 Years 至 75 Years（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 between 65 and 75 years of age
- •Previously untreated patients
排除标准
- •Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
- •Primary or associated amyloidosis
- •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
- •HIV or hepatitis B or C positivity
- •Patients who had geographic, social or psychological conditions which might prevent adequate follow-up
结局指标
主要结局
Overall survival
次要结局
- Best response rate
- Progression-free survival
- Survival after progression
- Toxicity