Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone
研究概览
简要总结
This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, 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
Lenalidomide
Lenalidomide/Low dose Dex (LLD)
干预措施: Lenalidomide/Low dose Dex (Drug)
Lenalidomide
Lenalidomide/Low dose Dex (LLD)
干预措施: Lenalidomide (Drug)
Bortezomib/Lenalidomide
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
干预措施: Bortezomib/Lenalidomide/ Low dose Dex (Drug)
结局指标
主要结局
comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone
时间窗: Four years
次要结局
未报告次要终点