NCT00932217Unknown3 期
Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 主要终点
- febrile episode
研究概览
简要总结
To evaluate the difference in the incidence of febrile episodes in patients undergoing stem cells mobilization with chemotherapy and filgrastim versus chemotherapy and lenograstim.
A febrile episode will be considered as: body temperature > 38°C for two measurements in the 24 hours with an interval of 6 hours at least between the two measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 70 years
- •Diagnosis of multiple myeloma
- •ECOG < 2 to be evaluated at baseline, after the induction chemotherapy
- •Indication to the mobilization with high dose cyclophosphamide chemotherapy
- •Normal blood counts: neutrophils > 1500/μl; platelets > 100.000/μl; hemoglobin > 10 g/dl.
- •Liver and renal function: SGOT/AST, SGPT/ALT; bilirubin < 1.5 times the upper limit of the normal ranges; creatinine < 2 times the upper limit of the normal ranges.
- •Interval from previous induction chemotherapy to high dose chemotherapy between 30 and 60 days
- •ECG e/o Echocardiogram within age related normal range
- •Negative HCV and HbsAg
- •Must be willing and able to fill in the patient's diary
- •Written informed consent
排除标准
- •Documented and/or suspected infections
- •Uncontrolled concurrent illness
- •Documented cardiac dysfunction
研究组 & 干预措施
filgrastim
Active Comparator
patients mobilized with filgrastim
干预措施: filgrastim (Drug)
lenograstim
Active Comparator
patients mobilized with lenograstim
干预措施: lenograstim (Drug)
结局指标
主要结局
febrile episode
时间窗: 30 days
次要结局
- Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety(30 days)
研究者
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