JPRN-jRCTs031180336已完成2 期
Phase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for multiple myeloma
Sakaida Emiko0 个研究点目标入组 22 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1) Patients diagnosed with multiple myeloma based on IWMG criteria
- •2) Bone marrow plasma cells under 5% after chemotherapy
- •3) Lenalidomide treatment under 4 cycles
- •4) More than 4 weeks after the beginning day of the last chemotherapy
- •5) Age 20-70
- •6) ECOG PS 0-2
- •7) Within 14 days prior to registration
- •Neutrophil over 1,000/mm3
- •Hemoglobin over 8.0g/dl
- •Platelet over 100,000/mm3
- •GOT, GPT under 2.5 times the upper limit of normal level
- •Total bilirubin under 2.0mg/dl
- •Creatinine under 2.0mg/dl
- •ECG WNL or trivial change without any symptoms
- •SpO2 over 95%
- •8) More than 3 months survival expected
- •9) Informed consent obtained
排除标准
- •1) Pregnant or lactating females. Patients who cannot do contraception.
- •2) Complications of active other cancers.
- •3) Severe psychological disorder
- •4) HBsAg positive or HBV-DNA positive.
- •5) HIV-Ab positive.
- •6) Plasma cells in the peripheral blood.
- •7) Severe drug allergy.
- •8) Active infection.
- •9) Any other problems regarded as disqualification by doctors.
研究者
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