Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma
1 other identifier
interventional
530
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Sep 2025
Shorter than P25 for phase_3 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
July 18, 2025
July 1, 2025
2 years
August 28, 2024
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of VTE within 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.
6 months
Secondary Outcomes (1)
Side effects of aspirin and rivaroxaban within 6 months
6 months
Study Arms (2)
Aspirin
ACTIVE COMPARATORAspirin,100mg qd, for six months
Rivaroxaban
EXPERIMENTALRivaroxaban, 10mg qd, for six months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2024
First Posted
August 30, 2024
Study Start
September 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
July 18, 2025
Record last verified: 2025-07