NCT00281476已完成1 期
The Effect of High Dose Simvastatine on Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
研究概览
简要总结
The purpose of the study is to evaluate the effect of high doses of Simvastatine on bone metabolisme and biochemical markers of disease in Multiple Myeloma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •multiple myeloma-patients in need of treatment
- •stable og progressive disease
- •age = or > 18 years
- •performance status < 3
- •life expectancy > 3 months
排除标准
- •pregnancy
- •patients incapable of giving personally concent
- •renal insufficiens with creatinine clearance below 25 ml/min
- •alanin aminotransferasis > 2,5 x upper reference limit
- •thyroxine below lower reference limit
- •known familiar muscle-disease ar previous myopati
- •creatinine kinase > 10 x upper reference limit
- •medication with drugs with known interactions wiht simvastatine
结局指标
主要结局
Response estimated by internationally approved criteria after 8 weeks of intermittend treatment with simvastatine
时间窗: 8 weeks after treatment start
次要结局
- Changes in markers of bone metabolisme after 8 weeks of intermittend treatment with simvastatine(8 weeks after start of treatment)
- Toxicity according to CTC after 8 weeks of intermittend treatment with simvastatine(8 weeks after start of treatment)
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