Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma

NCT ID: NCT06580223

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-01

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, 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.

Conditions

Multiple Myeloma; Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aspirin

Aspirin,100mg qd, for six months

Group Type: ACTIVE_COMPARATOR

Aspirin 100mg

Intervention Type: DRUG

Aspirin, enteric coating of tablets, oral administration

Rivaroxaban

Rivaroxaban, 10mg qd, for six months

Group Type: EXPERIMENTAL

Rivaroxaban 10mg

Intervention Type: DRUG

Rivaroxaban, tablets, oral administration.

Interventions

Aspirin 100mg

Aspirin, enteric coating of tablets, oral administration

Intervention Type: DRUG

Rivaroxaban 10mg

Rivaroxaban, tablets, oral administration.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Wuhan, Hubei, China

Countries

China

Central Contacts

Chunyan Sun

Role: CONTACT

suncy0618@163.com

85726007

Other Identifiers

UHCT240465

Identifier Type: -

Identifier Source: org_study_id