JPRN-UMIN000009391已完成1 期
Safety and efficacy of lenalidomide cyclophosphamide and dexamethasone (RCd) therapy in Japanese elderly patients with multiple myeloma, a phase I/II study - RefLEX-study Therapy for Refractory or relapsed elderly myeloma with Lenalidomide, cyclophosphamide (Endoxan) and deXamethasone.
KT-MM0 个研究点目标入组 30 人开始时间: 2012年11月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 70years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) untreated patients without a history of pretreatment 2) patients with a past history of allergy to the drugs described in the protocol 3) patients with a past history of using lenalidomide 4) patients who are expected to be need radiation against local disease or for palliative therapy, at registration. 5) patients who have any amyloidosis 6) patients who have uncontrollable diabetes mellitus 7) patients with a past history of angina or myocardial infarction and who have arrhythmia treated with anti-arrhythmic. 8) patients with a past history of cerebral infarction. 9) patients with a past history of venous or arterial thrombosis. 10) patients who have or suspected of having a serious active infection 11) patients who have renal failure, requiring hemodialysis. 12) patients who have liver cirrhosis, diagnosed biopsy or clinical data. 13) patients who have had a complication of active double cancer* within the past 5 years * Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment or lesions corresponding to intramucosal carcinoma (excluding cervical carcinoma presenting in FIGO Stage I) 14) positive test for HBs antigen or HCV antibody or HIV antibody. 15) patients who use major tranquilizer, antidepressant, or antimanic drugs. 16) patients who have serious mental disorders such as schizophrenia 17) other patients who are in the opinion of the caring investigator, unfit for enrollment in the study
研究者
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