NCT01816620已完成2 期
An Open-label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Dexamethasone (LDex) in Patients With Newly Diagnosed POEMS Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Hematological response rate
研究概览
简要总结
The purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed POEMS syndrome.
详细描述
The investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment.
The primary endpoint would be hematological response rate according to international myeloma working group (IMWG) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (ONLS) score.
This study expects to enroll approximately 41 subjects.
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
- •Patients must understand and voluntarily sign an informed consent form.
- •Older than 18 years old at the time of signing consent.
- •Meet the diagnostic criteria of POEM syndrome.
- •Must be cytotoxic treatment naive. However, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (IVIG) therapy is allowed.
- •Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
- •Male subjects must agree to use condoms throughout study drug therapy.
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or lactating females.
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count(ANC) of<1.0×10E9 cell/L. Platelet count<50×10E9 cell/L. Renal failure requiring dialysis. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times of the normal upper limit.
- •Prior history of malignancies, but not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and T1a or T1b prostate cancer.
- •Known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy.
- •Prior use of cytotoxic drugs.
- •Subjects who are unable or unwilling to undergo antithrombotic therapy.
研究组 & 干预措施
Lenalidomide, dexamethasone
Experimental
Lenalidomide 10mg qd d1-21 & dexamethasone 40mg qw d1,8,15,22
干预措施: Lenalidomide, Dexamethasone (Drug)
结局指标
主要结局
Hematological response rate
时间窗: last day of the LDx treatment regimen (up to 9 months)
Neurological response rate defined by ONLS score
时间窗: last day of the LDx treatment regimen (up to 9 months)
次要结局
- response rate of critical organs(every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months)
- Time to initial neurological response(every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months)
- Overall survival(From date of first diagnosis until the date of death from any cause, otherwise patients will be censored in June, 2018 (up to 5 years))
- Relapse free survival(From date of first diagnosis until the date of first documented relapse or date of death from any cause, whichever came first, otherwise patients will be censored in June, 2018 (up to 5 years))
- Response rate of serum vascular endothelial growth factor (VEGF) level(every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months)
- adverse events(throughout the treatment and until 30 days after the administration of the last dose of a study drug)
- time to the best neurological response(every month during the first 3 months calculated from the day study started, then every 3 months in the next 9 months)
研究者
Jian Li
Associate professor of Hematology Department
Peking Union Medical College Hospital
研究点 (1)
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