ACTRN12611000561987已完成3 期
A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex), investigating the haematologic response after 3 cycles of therapy, in untreated patients with systemic light-chain (AL) amyloidosis
Australasian Leukaemia and Lymphoma Group (ALLG)0 个研究点目标入组 110 人开始时间: 2011年6月1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
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Histologic diagnosis of amyloidosis.
- •Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis or immunohistochemistry of amyloid deposits must provide clear evidence of kappa or lambda light chains in those who present with peripheral neuropathy or heart as the dominant organ involvement.
- •Not eligible for transplant with melphalan 200 mg/m2. Patients who are eligible for transplant with melphalan 200 mg/m2 but decline the procedure, can be enrolled in the study, but are stratified in a separate stratum before randomization.
- •Eastern Cooperative Oncology Group performance status 0, 1 or 2.
- •Measurable disease; at least one of the following criteria:
- •Monoclonal protein more than 10 g/L in serum,
- •Amyloid-forming (involved) free light chains greater than 75 mg/L with an abnormal kappa-lambda ratio,
- •Difference between involved and uninvolved free light chains grater than 50 mg/L
- •Bone marrow with a clonal predominance.
- •Symptomatic organ involvement (heart, kidney, liver/Gastrointestinal tract, peripheral nervous system).
- •Hemoglobin of 11 g/dL, absolute neutrophil count of 1500/microL, platelets of 140,000/microL.
- •Total bilirubin less than 2.5 mg/dL, alkaline phosphatase less than 5 times the upper limit of normal, Alanine transaminase 3 times the upper limit of normal (patients with a documented history of Gilbert’s disease who have a total bilirubin (predominantly unconjugated) greater than 2.5mg/L without any other liver function test abnormalities are still eligible)
- •Estimated glomerular filtration rate by the modification of diet in renal disease formula greater than 30 ml/min.
排除标准
- •Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.
- •Isolated soft tissue involvement.
- •Presence of non-AL amyloidosis.
- •Previous treatment for plasma cell disease. A single previous cycle of dexamethasone or steroid equivalent (maximum cumulative dexamethasone dose 160 mg) is allowed; in this case baseline data must be obtained after steroid administration. Previous stem cell harvest is allowed, provided that mobilization is performed with granulocyte colony stimulating factor only.
- •Bone marrow plasma cells greater than 30 percent.
- •Cardiac stage three disease
- •Chronic atrial fibrillation
- •Supine systolic blood pressure less than 100mmHg or symptomatic orthostatic hypotension or clinically important autonomic disease
- •Grade 3 sensory or grade 1 painful peripheral neuropathy.
- •Clinically overt multiple myeloma with lytic bone lesions
- •Patients with uncontrolled infection or active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- •Patients with hypersensitivity to bortezomib, boron or mannitol.
研究者
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