ISRCTN34235460已完成3 期
A randomised, multi-centre trial to assess the feasibility of conducting a future phase III randomised trial in primary amyloidosis, comparing cyclophosphamide, thalidomide and dexamethasone with stem cell transplantation in patients with low risk of treatment related mortality and cyclophosphamide, thalidomide and dexamethasone with Mel-Dex in patients with high risk of treatment related mortality
niversity College London (UK)0 个研究点目标入组 48 人开始时间: 2007年1月26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
- 48
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
- •2. Newly diagnosed as having systemic AL amyloidosis who have:
- •2.1. Diagnostic Congo red histology confirming amyloid deposits
- •2.2. Immunohistochemical exclusion of Systemic (AA) and Transthyretin (TTR) amyloidosis
- •2.3. Exclusion of genetic mutations associated with hereditary amyloidosis whenever doubt about the diagnosis exists, according to Network Advisory Committee (NAC) current practice
- •2.4. Underlying plasma cell dyscrasia that can be identified and monitored by Freelite serum free light chain assay as follows: absolute serum free light chain concentration more than or equal to 100 mg/l associated with an abnormal kappa/lambda ratio
- •2.5. Amyloid-related organ dysfunction or organ syndrome
- •3. Capable of providing written, informed consent
- •4. Estimated life expectancy of at least six months
- •5. Prepared to use contraception in accordance with (and consent to) the Pharmion Risk Management Programme
- •6. Women of Child-Bearing Potential (WCBP) must agree to use TWO methods of contraception beginning two weeks prior to the start of thalidomide, while on thalidomide and four weeks after the last dose of thalidomide. The two methods of contraception must include one highly effective method and one additional effective (barrier) method, as outlined in the Pharmion Risk Management Programme
- •7. Male patients (including those who have had a vasectomy) must use condoms when engaging in heterosexual activity with WCBP while on thalidomide and four weeks after the last dose of thalidomide, as outlined in the Pharmion Risk Management Programme
排除标准
- •1. Overt symptomatic multiple myeloma
- •2. Bone marrow plasmacytosis more than 10%
- •3. Underlying Immunoglobulin M (IgM) paraproteinaemia
- •4. Amyloidosis of unknown or non AL type
- •5. 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)
- •6. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome)
- •7. Isolated soft tissue involvement
- •8. Severe peripheral neuropathy causing significant functional impairment
- •9. New York Heart Association (NYHA) class IV heart failure
- •10. Liver involvement by amyloid causing bilirubin more than 1.5 times upper limit of normal
- •11. Previous treatment for systemic AL amyloidosis
- •12. Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas
- •13. Pregnant, lactating or unwilling to use adequate contraception
- •14. Intolerance/sensitivity to any of the study drugs
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