Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.
详细描述
Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in multiple myeloma, for many years.
Advances in systemic and supportive therapy increased remission rates and overall survival, but multiple myeloma still remains an incurable haematological malignancy. Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60%.
Due to its activity, Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •untreated myeloma patients
- •age >65 years of age or younger but excluded from transplant procedure
- •Durie & Salmon stage II or III myeloma and measurable disease.
- •Patients agreed to use contraception
排除标准
- •other cancer
- •psychiatric disease and any grade 2 peripheral neuropathy
结局指标
主要结局
Response Rate
Event Free Survival
Progression Free Survival
次要结局
- Overall Survival
- Safety