JPRN-UMIN000019917已完成2 期
Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma - Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma (GHSG MM-01)
Gifu University Hospital0 个研究点目标入组 20 人开始时间: 2015年11月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Patients who have received treatment with lenalidomide (2) Patients who have hypersensitivity to lenalidomide or dexamethasone (3) non-secretory myeloma, solitary plasmacytoma, plasma cell leukemia, of POEMS syndrome patients (4) HBs antigen positive, HCV antibody-positive, HTLV-I antibody-positive cases, of HIV antibody-positive patients (5) Patients with a history of malignancy (6) Patients with pregnancy, patients who may be pregnant, or patients during lactation (7) uncontrolled liver dysfunction, renal dysfunction, cardiac dysfunction, lung dysfunction, diabetes, A high blood pressure, infections (8) patients with severe mental disorders (9) patients with deep vein thrombosis or pulmonary embolism (10) Patients who are regarded as inappropriate for participation to this clinical study by attending physicians
研究者
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Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002POEMS SYNDROMEMedDRA version: 9.1Level: SOCClassification code 10029205EUCTR2008-003202-33-ITISTITUTO CLINICO HUMANITAS
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The purpose of the study is to determine if the drug lenalidomide (Revlimid®) is able to improve anaemia (low red blood count) and reduce the number of blood transfusions that you require because of Myelodysplastic Syndrome (MDS). The other purpose of the study is to evaluate the effect of the study drug (lenalidomide) on the genetic abnormality (changes in the cell characteristics) associated with MDS.Myelodysplastic Syndrome (MDS) associated with a Del (5q) cytogenetic abnormalityMedDRA version: 16.0 Level: LLT Classification code 10067097 Term: 5q minus MDS System Organ Class: 100000004864EUCTR2004-005101-29-GBKing's College Hospital NHS Foundation Trust44