Search for Predictive Markers of Efficacy of Epoetin Beta (NEORECORMON) in the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Chemotherapy or Myelodysplastic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- response to erythropoietin
研究概览
简要总结
Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.
详细描述
Anemia is common among cancer patients and the treatment of choice is now Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to treatment. Thus, only 50-60% of patients with multiple myeloma or non-Hodgkin lymphoma respond to ESAs. The purpose of this study is to evaluate the predictive value of endogenous erythropoietin rate on the response to erythropoietin beta. First, by confirming the predictive value of endogenous erythropoietin observed / predicted ratio on this response. Then if it is confirmed by establishing the optimal value of this ratio.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 over 18
- •patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
- •indication of ESAs therapy with Hb < 11g/dl
排除标准
- •uncontrolled hypertension
- •anemia due to deficiency
- •pregnant and lactating women
- •patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion
结局指标
主要结局
response to erythropoietin
时间窗: 12 weeks
* Complete response : increase of 2g/dl of erythropoietin rate or stopping of transfusion requirements. * Partial response : increase of 1 to 2g/dl rate of erythropoietin or 50% reduction of transfusion requirements.
次要结局
- endogenous erythropoietin rate(Within 8 days before inclusion)
- hemoglobin rate(Weeks 0,4,8 and 12)
- Number of transfusions during the duration of the study(12 weeks)