A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.
详细描述
Thalidomide has recently emerged as an effective treatment for patients with myeloma refractory to conventional chemotherapy. So far only limited experience is available on thalidomide for newly diagnosed myeloma. Therefore the Nordic Myeloma Study Group decided to perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone + thalidomide/placebo. The study design is a multicentre double-blind randomised placebo-controlled trial. Mainly patients >65 years of age will be included since patients <65 years will be treated with high dose chemotherapy with autologous stem cell support. The primary end-point is overall survival. Secondary end-points are quality of life, response rate, time to response, response duration and toxicity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma in need of treatment
排除标准
- •Previous treatment against multiple myeloma
- •Need of high dose chemotherapy with autologous stem cell support
- •Women in fertile age
- •Psychiatric disease or mental reduction leading to lack of cooperation
- •Lack of consent
- •Life expectancy below 3 months
- •Active cancer of other etiology
研究组 & 干预措施
A
干预措施: thalidomide (Drug)
A
干预措施: placebo (Drug)
B
干预措施: thalidomide (Drug)
B
干预措施: placebo (Drug)
结局指标
主要结局
overall survival
时间窗: october 2007
次要结局
- Quality of life(october 2007)
- Time to response(october 2007)
- Frequency of response(october 2007)
- Time to progression(october 2007)
- Time to 2. response(october 2007)
- Frequency of 2. response(october 2007)
- Time to 2. progression(october 2007)
- Toxicity(october 2007)
- Time to definitive treatment failure(october 2007)