ISRCTN06413384已完成3 期
A randomised phase III study on the effect of thalidomide combined with Adriamycin®, dexamethasone and high dose melphalan in patients with multiple myeloma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 450 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
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 II or III according to the Salmon and Durie criteria
- •2. Age 18 to 65 years inclusive
- •3. World Health Organisation (WHO) performance status zero to three
- •4. Negative pregnancy test at inclusion if applicable
- •5. Written informed consent
排除标准
- •1. Known intolerance to thalidomide
- •2. Systemic AL amyloidosis
- •3. Previous chemotherapy or radiotherapy except two cycles of melphalan/prednisone or local radiotherapy in case of local myeloma progression
- •4. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II to IV)
- •5. Significant hepatic dysfunction (serum bilirubin greater than or equal to 30 micromol/l or transaminases greater than or equal to 25 times normal level), unless related to myeloma
- •6. Patients known to be Human Immunodeficiency Virus (HIV)-positive
- •7. Patients with active, uncontrolled infections
- •8. Patients with a history of active malignancy during the past five years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- •9. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women)
- •10. Patients less than or equal to 55 years with a Human Leukocyte Antigen (HLA)-identical sibling who will undergo myeloablative Allogeneic Stem Cell Transplantation (AlloSCT)
研究者
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