ISRCTN90692740已完成不适用
Randomised phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 420 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
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
- 性别
- All
入选标准
- •1. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria
- •2. Age >65 years
- •3. WHO performance status 0-3
- •4. Measurable tumorparameter (M-protein or Bence Jones proteïnuria)
- •5. Written informed consent
排除标准
- •1. Known intolerance to Thalidomide
- •2. Systemic AL amyloidosis
- •3. Polyneuropathy
- •4. Severe cardiac dysfunction (NYHA classification II-IV)
- •5. Severe pulmonary dysfunction
- •6. Significant hepatic dysfunction (serum bilirubin =30 mmol/l or transaminases =25 times normal level), unless related to myeloma
- •7. Renal failure with dependency on dialysis
- •8. Patients with active, uncontrolled infections
- •9. Pre-treatment with cytostatic drug or alpha interferon
- •10. Patients known to be HIV-positive
- •11. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
研究者
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