KCT0006266尚未招募未知
Phase II trial of bortezomib, lenalidomide, and dexamethasone in patiens with high-risk smoldering myeloma
Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 21 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 75?(Year)（—）
- 性别
- All
入选标准
- •1.Age 19~75
- •2.High-risk smoldering multiple myeloma (2~3 of the followings)
- •- serum M-protein = 2 g/dL
- •- Serum free light chain ratio (involved/uninvolved) = 20
- •- Bone marrow plasma cells = 20%
- •3.Adequate organ function
- •- Absolute neutrophil count = 1.0 x 109/L
- •- Platele = 50 x 109/L
- •(= 30 x 109/L if myeloma involvement is > 50% in the bone marrow)
- •- Hemoglobin = 8.0 g/dL (?? ??)
- •- Creatinine clearance = 30 mL/minute
- •- Bilirubin ???? = 1.5 x upper normal limit
- •- AST and ALT = 3 x upper normal limit
- •4.Eastern Cooperative Oncology Group performance scale 0, 1 or 2
- •5.Expected survival > 3 months
- •6.Well-controlled HBV or HCV infection
- •7.Written informed consents
排除标准
- •Active multiple myeloma
- •2.Low-intermediate risk SMM
- •3.Monoclonal gammopathy of undetermined significance
- •4.Prior treatment for SMM
- •5.Pregnant or lactating women
- •6.Myocardial infarct within 6 months, heart failure of NYHA Class III~IV, uncontrolled ventricular arrhythmia, history of severe coronary arterial disease
- •7.Uncontrolled hypertension or diabetes
- •8.Neuropathy grade 3~4
- •9.HIV infection
- •10.Patients with severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric disorders
- •11.Hypersensitivity to the investigational products
- •12.Synchronous or metachronous malignant tumor other than SMM within 5 years
- •(except for adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, adequately resected differentiated thyroid cancer, intraepithelial carcinoma of the neck or breast, or prostate cancer that can be monitored for progress status without any treatment).
研究者
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