ISRCTN33283585已完成2 期
A pilot study of relapsed or refractory patients using Velcade™ (bortezomib) combination chemotherapy in AL amyloidosis
niversity College London (UCL) (UK)0 个研究点目标入组 52 人开始时间: 2010年7月30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
- 52
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. Aged 18 years or greater, either sex
- •2. Systemic AL amyloidosis who fulfil all the following criteria:
- •2.1. Measurable clonal disease in the serum as defined by either a serum paraprotein of greater than 7 g/L or the abnormal component of the serum free light chain greater than 75 mg/L (abnormal ratio only in case of renal failure)
- •2.2. Amyloid related organ dysfunction or organ syndrome
- •3. Following prior chemotherapy or prior autologous stem cell transplant, evidence of either:
- •3.1. Clonal disease relapse
- •3.2. Refractory clonal disease
- •3.3. Inadequate clonal response (defined as less than a 90% reduction in serum clonal markers)
- •4. Capable of providing written informed consent
排除标准
- •1. Overt symptomatic non-amyloid manifestations of multiple myeloma
- •2. Amyloidosis of unknown or non-AL type
- •3. Localised AL amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ)
- •4. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome)
- •5. Allogeneic stem cell transplantation
- •6. Solid organ transplantation
- •7. Severe peripheral neuropathy or autonomic neuropathy causing significant functional impairment
- •8. Thrombocytopaenia (platelet count less than 50 x 10^9/l)
- •9. Neutropaenia (neutrophil count less than 1 x 10^9/l)
- •10. Liver involvement by amyloid causing bilirubin greater than 2 times or alkaline phosphatase greater than 4 times upper limit of normal
- •11. Estimated glomerular filtration rate (eGFR) less than 20 ml/min but not on dialysis (patients on dialysis are not excluded)
- •12. Ejection fraction less than 40%
- •13. New York Heart Association (NYHA) class IV heart failure
- •14. Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
- •15. Estimated life expectancy of less than 3 months
- •16. Active hepatitis B or C or human immunodeficiency virus (HIV) infection
- •17. Previous cumulative anthracycline dose of greater than 200 mg/m2
- •18. Previous treatment with bortezomib combined with anthracycline and/or alkylator and/or immunomodulatory drugs (ImiD)
- •19. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas
- •20. Pregnant, lactating or unwilling to use adequate contraception
- •21. Intolerance/sensitivity to any of the study drugs
研究者
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