A Prospective Validation of the 4TS Risk Assessment Model in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias. ROADMAP-MM
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Symptomatic venous thromboembolism
研究概览
简要总结
Patients with newly diagnosed symptomatic multiple myeloma per IMWG criteria prior to therapy initiation are enrolled in the study. The aim of the study is to investigate clinical and disease related risk factors for venous thromboembolism (VTE) in these patients as well as possible biomarkers of hypercoagulability linked with the occurrence of venous thromboembolism at diagnosis and during the disease course. The purpose is to create a risk assessment model for VTE in newly diagnosed multiple myeloma patients and make the model more accurate by combining relevant clinical and disease characteristics with biomarkers of cellular and plasma hypercoagulability. A standardized clinical research form is completed for all patients at baseline, 3, 6 and 12 month follow up to include relevant clinical, patient-related, disease-related and treatment related data. Blood sampling also takes place at baseline and 3,6,12 months to assess multiple biomarkers of plasma and cellular hypercoagulability. In addition lowe limb ultrasound is performed at baseline, 6 and 12 months. The primary endpoint is VTE occurrence. Following the elaboration of the ROADMAP-CAT-MM risk assessment model we will prospectively validate it. We expect that patients who are classified, as high risk according to the ROADMAP-CAT-MM will experience symptomatic VTE more frequently and will have higher morbidity and mortality rates during the follow-up. The prospective validation of the ROADMAP-CAT-MM will provide guidance for the use and choice of thromboprophylaxis in these patients and will identify high risk patients eligible for thromboprophylaxis with low molecular weight heparin (tinzaparin).
In addition to symptomatic patients with multiple myeloma the study aims to investigate VTE risk in all plasma cell dyscrasias and will recruit patients with monoclonal gammopathy of undetermined significance, asymptomatic multiple myeloma, primary amyloidosis and Waldenström's macroglobulinemia.
详细描述
Hypothesis: We expect that patients who are classified, as high risk according to the ROADMAP-CAT-MM will experience symptomatic VTE more frequently and will have higher morbidity and mortality rates during the follow-up. The prospective validation of the ROADMAP-CAT-MM (combined or not with biomarkers of hypercoagulability) will allow to identify patients eligible for long-term thromboprophylaxis with intermediate dose of tinzaparin.
Objectives of the study Primary objective: using the ROADMAP-CAT-MM we will identify high risk patients who will be eligible for long-term thromboprophylaxis.
Secondary objective: to identify patients with biological resistance to the fixed dose of postoperative thromboprophylaxis LMWH and to evaluate its clinical relevance.
End-points of the study Primary end-point: the occurrence of symptomatic VTE (DVT and/or PE) and asymptomatic DVT, or superficial venous thrombosis of the lower or upper limb, central vein catheter thrombosis or venous thrombosis of rare localization. Venous thrombosis has to be confirmed with any of the following assays: echo-Doppler, CT or MRI angiography, or scintigraphy or CT scan. Occurrence of asymptomatic venous thrombosis found during routine imaging for staging will also be included in the primary end point. Combined end-point including all the above types of venous thrombosis will also be evaluated.
Secondary end-points: mortality, major bleeding, cancer evolution and morbidity during follow-up.
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
- •Newly Diagnosed patients with symptomatic multiple myeloma
- •Previously untreated patients
排除标准
- •Age younger than 18 years
- •Life expectancy less than 6 months
- •Ongoing pregnancy, major psychiatric disorders
- •Recent (<6 months) episode of VTE or acute coronary syndrome
- •Active anticoagulant treatment (for any indication)
- •Scheduled open elective curative surgery under general anesthesia for abdominal or pelvic or lung cancer last 3 months
- •Hospitalization due to stroke or acute coronary syndrome or congestive heart failure or acute respiratory failure the last 3 months
- •Eligible patients had not undergone any surgery in the preceding 3 months.
结局指标
主要结局
Symptomatic venous thromboembolism
时间窗: 12 months
Symptomatic objectively confirmed venous thromboembolism
次要结局
- Mortality(12 months)
- Major Bleeding(12 months)
- Disease progression(12 months)
研究者
Meletios A. Dimopoulos
Professor MA Dimopoulos
University of Athens