Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma; Venous Thromboembolism
• Intervention / Treatment: Drug: Aspirin 100mg; Drug: Rivaroxaban 10mg

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, 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.

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chunyan Sun; Phone Number: 85726007; Email: suncy0618@163.com

Study Locations

• China
  • Hu Bei
    • Wuhan, Hu Bei, China, 430022
      • Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Aspirin,100mg qd, for six months	Drug: Aspirin 100mg; Aspirin, enteric coating of tablets, oral administration
Experimental: Rivaroxaban; Rivaroxaban, 10mg qd, for six months	Drug: Rivaroxaban 10mg; Rivaroxaban, tablets, oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of aspirin and rivaroxaban within 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.	6 months

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Venous Thromboembolism; aspirin; rivaroxaban; thromboprophylaxis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Embolism and Thrombosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Thromboembolism; Venous Thromboembolism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Aspirin
• Other Study ID Numbers: UHCT240465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No