Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 529
- 主要终点
- Disease history and VETD risk factors. Chemotherapy protocol for multiple myeloma. Therapeutic used for VETD prevention (LWMH, anticoagulants, antiplatelets or none)
研究概览
简要总结
Patients with multiple myeloma have seen their survival rate strongly improved with the use of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE) up to 20%. In these conditions, a prevention of this risk can be proposed by physician with either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending the new recommendations on the management of VTED, the purpose of this study is to describe in real life conditions the management by oncologists of the thrombo embolic risk for such patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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 with multiple myeloma receiving a chemotherapy protocol including thalidomide or lenalidomide
排除标准
- •Patients involved in an interventional clinical trial
结局指标
主要结局
Disease history and VETD risk factors. Chemotherapy protocol for multiple myeloma. Therapeutic used for VETD prevention (LWMH, anticoagulants, antiplatelets or none)
时间窗: 4 months
次要结局
- PE and DVT rate at 4 months and one year. Bleedings and all relevant SAE and AE at 4 months and one year.(12 months)