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NCT Number: NCT06580223

Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Aspirin 100mg

Drug

Aspirin, enteric coating of tablets, oral administration

Rivaroxaban 10mg

Drug

Rivaroxaban, tablets, oral administration.

Primary outcomes

  1. Incidence of VTE within 6 months

    Time frame: 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 outcomes

  1. Side effects of aspirin and rivaroxaban within 6 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunyan Sun

CONTACT

[email protected]

85726007

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma: A Prospective, Multicenter, Open-Label, Randomized Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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