Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 736
- 试验地点
- 1
- 主要终点
- Rate of venous thromboembolism according to different thromboprophylaxis strategies
研究概览
简要总结
The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).
详细描述
This is an observational prospective cohort study aimed at assessing the efficacy of different types of thromboprophylaxis in MM patients; the setting is the GIMEMA network of the Italian haematological Centers.
The observation time for each patient will be of 3 years from the start of the active treatment for MM. Patients will remain in the study regardless of the stage of disease, type of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis, occurrence of thrombosis.
Four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis, cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age equal to or greater than 18 years of age.
- •New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group
- •First active treatment for MM started after recruitment in the study
- •Signed informed consent
排除标准
- •Patients having had thrombosis within 6 months before diagnosis of MM
- •Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs)
- •Ongoing first active treatment for MM initiated before the starting of the study.
结局指标
主要结局
Rate of venous thromboembolism according to different thromboprophylaxis strategies
时间窗: 3 years
Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed: 1. Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis 2. Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis 3. Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis.
次要结局
未报告次要终点