JPRN-UMIN000027780已完成未知
Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN003 study - Randomized study of PCD versus PD in relapse or refractory myeloma. An AMN003 study
EP-CRSU Co.,Ltd0 个研究点目标入组 11 人开始时间: 2017年6月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 11
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Female patients who are lactating or pregnant 2.Multiple Myeloma of IgM subtype 3.Glucocorticoid therapy within14days 4.POEMS syndrome 5.Plasma cell leukemia or circulating plasma cells more than 2x109/L 6.Waldenstrom's Macroglobulinaemia 7.Patients with known amyloidosis 8.Chemotherapy with approved or investigation anticancer therapeutics within21days prior tostarting pomalidomide treatment 9.Focal radiation therapy within7days prior to start of pomalidomide.Radiation therapy to an extended field involving a significant volume of bone marrow within21days prior to start of pomalidomide 10.Immunotherapy 11.Major surgery within28days 12.ActiveCHF, symptomatic is chaemia,or conduction abnormalities. Myocardial infarction within4months prior 13.KnownHIV seropositive,hepatitis C infection,and/or hepatitis B(except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B these patients are allowed) 14.Patients with known cirrhosis 15.Second malignancy within the past3years16.Patients with MDS 17.Patients with steroid or lenalidomide hypersensitivity 18.Prior treatment with pomalidomide 19.OngoingGVHD 20.Patients with pleural effusions or ascites 21.Contraindication to any of the required concomitant drugs or supportive treatments 22.Any clinically significant medical disease or psychiatric condition
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