An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- hematologic response rate
研究概览
简要总结
The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits. The plasma cells can be killed and their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide, steroids, such as dexamethasone, and drugs that stimulate the immune system, such as lenalidomide.
The present trial studies the efficacy and safety of the combination of cyclophosphamide, lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated and need further therapy.
详细描述
This study will include previously treated patients with AL amyloidosis.
Primary objectives to determine the hematologic and organ response rate to the association of cyclophosphamide, lenalidomide and dexamethasone (CLD).
Secondary objectives
- to determine the safety of CLD,
- to determine time to response to CLD,
- to determine the duration of response to CLD,
- to assess survival of AL amyloidosis patients treated with CLD.
Patients receive 28-day cycles cyclophosphamide on days 1, 8 and 15, oral lenalidomide on days 1-21 and oral dexamethasone on days 1, 8, 15, and 22.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- •Prior treatment with the association of cyclophosphamide, lenalidomide and dexamethasone or with lenalidomide.
- •Requirement for other concomitant chemotherapy, immunotherapy or radiotherapy, or any investigational ancillary therapy.
- •Presence of other active malignancies, with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate specific antigen is within normal limits.
- •Clinically overt multiple myeloma.
- •Uncontrolled infection.
- •New York Heart Association (NYHA) class 4 heart failure.
- •Enzyme documented myocardial infarction within 6 months before enrollment.
- •Grade 2 or 3 atrioventricular block (Mobitz type I is permitted).
- •Repetitive ventricular arrhythmias at 24 h Holter electrocardiogram in spite of treatment with amiodarone.
- •Supine systolic blood pressure <90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of >20 mmHg in spite of being treated for orthostatic hypotension.
- •Prior history of thrombosis or venous thromboembolism or pulmonary embolism. Prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.
- •Indication to receive clopidogrel, ticlopidine or warfarin.
- •Factor X level <20%.
- •Poorly controlled diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months).
- •Previous or ongoing psychiatric illness (with the exclusion of reactive depression).
- •Pregnant or nursing women.
研究组 & 干预措施
1
The participants receive up to 9 28-day cycles of
- cyclophosphamide: 500 mg orally on days 1, 8, 15;
- lenalidomide: 15 mg orally on days 1-21;
- dexamethasone: 40 mg orally on days on days 1, 8, 15, 22.
干预措施: cyclophosphamide (Drug)
1
The participants receive up to 9 28-day cycles of
- cyclophosphamide: 500 mg orally on days 1, 8, 15;
- lenalidomide: 15 mg orally on days 1-21;
- dexamethasone: 40 mg orally on days on days 1, 8, 15, 22.
干预措施: lenalidomide (Drug)
1
The participants receive up to 9 28-day cycles of
- cyclophosphamide: 500 mg orally on days 1, 8, 15;
- lenalidomide: 15 mg orally on days 1-21;
- dexamethasone: 40 mg orally on days on days 1, 8, 15, 22.
干预措施: dexamethasone (Drug)
结局指标
主要结局
hematologic response rate
时间窗: at 3 months
次要结局
- organ response rate(at 3 months)
- time to response(every 28 days)
- time to progression(every 3 months for 3 years)
- survival(up to 3 years after treatment discontinuation)
- toxicity(continuous during treatment)
研究者
Giampaolo Merlini
Director, Amyloidosis Treatment and Research Center
Fondazione IRCCS Policlinico San Matteo di Pavia