Status:
NOT_YET_RECRUITING
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Multiple Myeloma
Venous Thromboembolism
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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, an...
Eligibility Criteria
Inclusion
- Newly diagnosed multiple myeloma (according to Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision))
- High risk of VTE (according to Expert consensus on the prevention and treatment of multiple myeloma related venous thromboembolism in China (2022))
- Life expectancy exceeding 12 months
- Gender: not specified, Age: 18-90 years
- Serum HIV antigen or antibody negative
- HCV antibody negative, or HCV antibody positive with HCV RNA negative
- Echocardiogram shows a left ventricular ejection fraction of ≥50%
- Ability to sign an informed consent form
Exclusion
- Pregnant women or women who are breastfeeding
- Active gastrointestinal ulceration
- Active bleeding
- 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.
- 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)
- Abnormal renal function (creatinine clearance \< 30 mL/min)
- Unable to cooperate in completing the clinical trial
- Already enrolled in other clinical studies
- Diagnosed with smoldering multiple myeloma or plasma cell leukemia
- Patients already on antiplatelet therapy for other cardiovascular or cerebrovascular diseases.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT06580223
Start Date
September 1 2025
End Date
September 1 2027
Last Update
July 18 2025
Active Locations (1)
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1
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022