Front-line Therapy with Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Induction Followed by Autologous Stem Cell Transplantation, CRd Consolidation and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Old
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 11
- 主要终点
- rate of stringent complete response
研究概览
简要总结
The purpose is to determine whether induction and consolidation treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRd), within an intensive program, warrant further investigation in clinical trials.
详细描述
The primary objective is to evaluate the sCR rate of the combination of carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients at the completion of consolidation therapy.
It's a multicenter, open label, non randomized, phase II study. 46 patients will be enrolled.
Induction: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Stem Cell Harvest: High dose Cyclophosphamide with intensification consolidation: 4 cycles of 28 Days with Carfilzomib/Lenalidomide and dexamethasone Maintenance : Lenalidomide 13 cycles of 28 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group
- •Subjects must have symptomatic myeloma with at least one CRAB criteria
- •Subjects must not have been treated previously with any systemic therapy for multiple myeloma
排除标准
- •Pregnant or lactating females
- •Evidence of mucosal or internal bleeding and/or platelet refractory
- •Acute active infection requiring treatment
- •Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks
- •Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy
- •Subjects not eligible for high dose therapy
研究组 & 干预措施
Front line therapy
Induction: 4 cycles of 28 days of Carfilzomib/Lenalidomide/Dexamethasone Stem Cell Harvest+Intensification Consolidation 4 cycles of 28 days of Carfilzomib/ Lenalidomide/Dexamethasone Maintenance: Lenalidomide 13 cycles of 28 days
干预措施: Carfilzomib/Lenalidomide/Dexamethasone (Drug)
结局指标
主要结局
rate of stringent complete response
时间窗: 12 months
completion of consolidation
次要结局
未报告次要终点