Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether aspirin or rivaroxaban, a type of blood thinner, can help prevent blood clots in patients with multiple myeloma, a type of cancer that affects the blood. Researchers want to see which of these two treatments is more effective and safe for patients who are at high risk of developing blood clots related to their condition. The study is specifically looking at adults aged 18 to 90 who have newly diagnosed multiple myeloma and a life expectancy of over a year.

To participate, patients must meet certain criteria, such as having a specific diagnosis of multiple myeloma and being considered at high risk for blood clots. Those who are pregnant, have active bleeding, or certain other health issues won't be eligible. If chosen to participate, individuals can expect to receive either aspirin or rivaroxaban and will be monitored by the study team to ensure their safety and gather important information about how well the treatments work. This study will help improve care for patients with multiple myeloma and potentially reduce the risk of serious complications from blood clots.

Gender

ALL

Eligibility 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:
• • 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.