NCT06580223

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Aspirin 100mg	Aspirin, enteric coating of tablets, oral administration
DRUG	Rivaroxaban 10mg	Rivaroxaban, tablets, oral administration.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-08-30
• Last updated: 2025-07-18

Locations

1 site across 1 country: China