A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).
详细描述
The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.
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
- •Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
- •Age > 18 years
- •ECOG performance status of 0,1 or 2
- •Life expectancy of at least 12 weeks
排除标准
- •Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
- •Severe uncontrolled ventricular arrhythmias
- •ECG evidence of acute ischemia or active conduction system abnormalities
- •Female subjects either pregnant or breast-feeding
- •Serious medical or psychiatric illness
- •Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)
- •History of severe hepatic dysfunction
- •Active infections or HIV positivity
- •Uncontrolled insulin-dependent diabetes mellitus
- •Uncompensated major thyroid or adrenal dysfunction
- •Hemodialysis or peritoneal dialysis
- •Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
- •ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
结局指标
主要结局
Overall response rate
时间窗: 4 months
IMWG criteria
Complete remission rate
时间窗: 4 months
IMWG
At least Very good partial remission rate
时间窗: 4 months
IMWG
次要结局
- Progression free survival(24 months)
- Overall survival(24 months)
- Percentage of patients able to perform stem cell transplantation(12 months)
- Safety(4-8 months, according to protocol)
研究者
Pellegrino Musto
Onco-Hematology Department Director at IRCCS-CROB Rionero in Vulture, Italy
IRCCS Centro di Riferimento Oncologico della Basilicata