Multiple Myeloma, Venous Thromboembolism
Conditions
Keywords
Multiple Myeloma, Venous Thromboembolism, aspirin, rivaroxaban, thromboprophylaxis
Brief summary
The aim of this study is to evaluate the efficacy and safety of aspirin and rivaroxaban in thromboprophylaxis in Chinese MM patients at high risk for MM-associated VTE.
Detailed description
Venous thromboembolism (VTE) is one of the most common and dangerous complications of Multiple Myeloma (MM). The occurrence of VTE can disrupt treatment plans, compromise patients' quality of life, and even threaten their lives, presenting significant challenges in clinical management. Although several guidelines recommend risk-stratified thromboprophylaxis, there is a deficiency in prospective validation, and most initial studies were conducted in Western cohorts. This prospective, multicenter, open-label, randomized study aims to compare the efficacy and safety of aspirin or rivaroxaban in preventing VTE in Chinese MM patients who are at high risk for VTE.
Interventions
DRUGAspirin 100mg
Aspirin, enteric coating of tablets, oral administration
DRUGRivaroxaban 10mg
Rivaroxaban, tablets, oral administration.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed multiple myeloma (according to Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision)) 2. High risk of VTE (according to Expert consensus on the prevention and treatment of multiple myeloma related venous thromboembolism in China (2022)) 3. Life expectancy exceeding 12 months 4. Gender: not specified, Age: 18-90 years 5. Serum HIV antigen or antibody negative 6. HCV antibody negative, or HCV antibody positive with HCV RNA negative 7. Echocardiogram shows a left ventricular ejection fraction of ≥50% 8. Ability to sign an informed consent form
Exclusion criteria
1. Pregnant women or women who are breastfeeding 2. Active gastrointestinal ulceration 3. Active bleeding 4. When initiating treatment, platelet count below 50 G/L, or with PT prolonged by more than 3 seconds, and APTT prolonged by more than 10 seconds. 5. Abnormal liver function (ALT or AST greater than 3 times the upper limit of normal, or total bilirubin greater than 2 times the upper limit of normal) 6. Abnormal renal function (creatinine clearance \< 30 mL/min) 7. Unable to cooperate in completing the clinical trial 8. Already enrolled in other clinical studies 9. Diagnosed with smoldering multiple myeloma or plasma cell leukemia 10. Patients already on antiplatelet therapy for other cardiovascular or cerebrovascular diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of VTE within 6 months | 6 months | Participants will receive a chest X-ray (or lung CT scan) and a color Doppler ultrasound of the limb blood vessels before the study begins, and then once monthly for the next six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects of aspirin and rivaroxaban within 6 months | 6 months | Testing indicators, including blood routine, urine routine, stool routine, liver and kidney function tests, electrolytes, blood glucose, and blood lipids, will be recorded before the study begins and then once weekly for the next six months. Other observational indicators, such as hemorrhagic events, nausea, vomiting, diarrhea, and abdominal distension, will also be recorded. |
Countries
China
Contacts
Primary ContactChunyan Sun
Outcome results
None listed