An Open, Randomized Clinical Phase I/II Trial to Investigate Maximum Tolerated Dose, Efficacy, and Safety of Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose (MTD) of CY (PO and IV) in combination with LEN/low-dose DEX
研究概览
简要总结
The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX and continuous low-dose CY administered orally compared to LEN in combination with low-dose DEX and single CY doses IV in patients with relapsed MM.
详细描述
This is an open, randomized, multicenter, phase I/II study with a parallel group design investigating an intravenous and an oral CY dosing schedule in combination with LEN and low-dose DEX in patients with refractory or relapsed MM. In phase I MTD of CY will be determined using a common dose escalation scheme with 3 to 6 patients per dose level. In phase II, efficacy and safety of the treatment regimens at the MTD will be investigated in 20 patients.
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
- 18 Years 至 —（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
oral application
oral application Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
intravenous application
intravenous application Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
To determine the maximum tolerated dose (MTD) of CY (PO and IV) in combination with LEN/low-dose DEX
时间窗: 3 years
To investigate the best objective response (EBMT criteria) to both treatment regimens
时间窗: 3 years
次要结局
- To investigate safety and tolerability of both treatment regimens(3 years)
- To investigate other efficacy parameters of both treatment regimens(3 years)