Randomized Phase II Study of Bortezomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Elderly Patients With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- 3-Year Progression-free survival (PFS)
研究概览
简要总结
To compare the efficacy and safety of bortezomib, lenalidomide and dexamethasone in elderly frail patients with newly diagnosed multiple myeloma.
详细描述
Group 1: 1 cycle will be repeated every 4 weeks
- Bortezomib 1.3mg/m2 SC D1, 8, 15
- Dose adjustment for more than 85 : 1.0mg/m2 SC D1, 8, 15
- Lenalidomide 25mg/d D1-21
- Dose adjustment for more than 75 : 15mg/d D1-21
- Dexamethasone 40mg D1, 8, 15, 22
- Dose adjustment for more than 75 years old: 20mg
- If it is difficult to maintain bortezomib due to unacceptable toxicity, it can early discontinue from Group 1.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Group 1: 1 cycle will be repeated every 4 weeks
Bortezomib 1.3mg/m2 SC D1, 8, 15 - Dose adjustment for more than 85 : 1.0mg/m2 SC D1, 8, 15
Lenalidomide 25mg/d D1-21
- Dose adjustment for more than 75 : 15mg/d D1-21
Dexamethasone 40mg D1, 8, 15, 22 - Dose adjustment for more than 75 years old: 20mg If it is difficult to maintain bortezomib due to unacceptable toxicity, it can early discontinue from Group 1.
<for patients with old age or frail>
Bortezomib 1.0mg/m2 SC D1, 8, 15
: Dose adjustment for more than 85 : 1.0mg/m2 SC D1,8,15 Lenalidomide 15mg/d D1-21 Dexamethasone 20mg D1, 8, 15, 22
干预措施: Bortezomib, Lenalidomide, Dexamethasone (Drug)
Group 2
Group 2: 1 cycle will be repeated every 4 weeks
Lenalidomide 25mg/d D1-21
- Dose adjustment for more than 75: 15mg Dexamethasone 40mg D1, 8, 15, 22
- Dose adjustment for more than 75: 20mg
<for patients with old age or frail>
- Lenalidomide 15mg/d D1-21
- Dexamethasone 20mg D1, 8, 15, 22
干预措施: Bortezomib, Lenalidomide, Dexamethasone (Drug)
结局指标
主要结局
3-Year Progression-free survival (PFS)
时间窗: 3-years after randomization
The time from randomization into the date of first observation of documented disease progression or death.
次要结局
- Assessment of response(accessed every each cycle (each cycle is 28days))
研究者
Kihyun Kim
Professor
Samsung Medical Center