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RECRUITING
NCT07907211
PHASE4

Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple Myeloma

Sponsor: Chen Lijuan

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the efficacy and safety of aspirin versus rivaroxaban for thromboprophylaxis in newly diagnosed multiple myeloma patients receiving immunomodulatory drug (IMiD)-based therapy. The main questions it aims to answer are: Does rivaroxaban reduce the incidence of venous thromboembolism (VTE) compared with aspirin in this patient population? What are the comparative safety profiles (particularly regarding bleeding events) of aspirin and rivaroxaban in this setting?

Official title: A Single-Center, Randomized Clinical Trial of Aspirin Versus Rivaroxaban for Thromboprophylaxis in Newly Diagnosed Multiple Myeloma Patients Receiving Immunomodulatory Agent-Based Therapy

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-02-01

Completion Date

2027-12-31

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Aspirin

Aspirin 0.1 g (100 mg) administered orally once daily as thromboprophylaxis in newly diagnosed multiple myeloma patients receiving immunomodulatory agent (IMiD)-based therapy. The enteric-coated tablet should be swallowed whole with water, preferably at least 30 minutes before meals; it should not be crushed, split, or chewed. Dose interruption is required if platelet count \< 50 × 10\^9/L or according to protocol-specified criteria.

DRUG

Rivaroxaban

Rivaroxaban 10 mg administered orally once daily as thromboprophylaxis in newly diagnosed multiple myeloma patients receiving immunomodulatory agent (IMiD)-based therapy. It may be taken with or without food. If a dose is missed, it should be taken immediately, and the next dose should be continued the following day. Discontinue for severe bleeding, acute renal insufficiency, or progressive decline in renal function indicators, or according to protocol-specified criteria.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China