NL-OMON38293已完成2 期
Bortezomib in combination with continuous low-dose oral cyclophosphamide and dexamethason followed by maintenance in primary refractory or relapsed bortezomib naïve multiple myeloma patients - Relapse myeloma; cyclofosfamide; bortezomib; maintenance.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >= 18 years
- •Stage II-III Multiple Myeloma
- •Relapse or primary refractory disease after initial chemotherapy
- •WHO performance status 0 - 2
- •Life expectancy of at least 6 weeks
- •ANC (absolute neutrophil count) >= 1.0x109/l
- •(or >= 0.5x109/l, if due to bone marrow infiltration by malignancy)
- •Platelet count >= 75x109/l
- •(or >= 50x109/l, if due to bone marrow infiltration by malignancy)
- •Written informed consent (present in patient*s file)
- •Patient is able and willing to use adequate contraception during therapy and for at
- •least 1 month after study;Patient has the ability to understand the requirements of the study
排除标准
- •Previous treatment with bortezomib
- •Urine production < 1.5 l/24h
- •Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0)
- •Pregnancy or positive pregnancy tests during study and for 1 month after final dose
- •of thalidomide
- •History of active malignancy during the past 5 years
- •(with the exception of basal carcinoma of the skin)
- •Active uncontrolled infections
- •Additional uncontrolled serious medical or psychiatric illness
研究者
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