multiple myeloma associated venous thromboembolism
Conditions
Interventions
Aspirin group:Aspirin,100mg qd
Rivaroxaban group:Rivaroxaban, 10mg qd
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
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
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 |
|---|---|
| Incidence of VTE within 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of aspirin and rivaroxaban within 6 months; | — |
Countries
China
Contacts
Public ContactChunyan Sun
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed