NCT07907211 Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple Myeloma

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 200 participants in total. It began in 2024-02-01 with a primary completion date of 2026-12-31.

Brief 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?

Eligibility Criteria

Inclusion Criteria: 1. Age 18 to 70 years at the time of screening. 2. Newly diagnosed multiple myeloma with measurable disease according to the Chinese Guidelines for the Diagnosis and Management of Multiple Myeloma (2020 revision). 3. Scheduled to receive immunomodulatory drug (thalidomide, lenalidomide, or pomalidomide)-based chemotherapy regimens. 4. No clinical history or imaging evidence of venous thromboembolism at the time of initial diagnosis. 5. Life expectancy \> 3 months. 6. Adequate renal function defined as an endogenous creatinine clearance (CrCl) ≥30mL/min calculated by the Cockcroft-Gault formula. 7. Absence of active systemic infectious disease requiring intravenous antimicrobial therapy. 8. Female patients of childbearing potential must have a documented negative serum pregnancy test at screening. Male and female patients of reproductive potential must agree to use highly effective contraception methods throughout treatment and for at least 3 months following the final dose. 9. Ability to understand the study procedures, comply with protocol follow-up visits, and voluntarily provide written informed consent signed by the patient or a legally authorized representative. Exclusion Criteria: 1. Active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or other known acquired/congenital immunodeficiency syndromes. 2. Baseline peripheral neuropathy or neuropathic pain ≥ Grade 2 according to NCI CTCAE version 5.0. 3. Diagnosis of plasma cell leukemia. 4. History of severe or recurrent venous/arterial thromboembolism prior to study enrollment. 5. History of clinically significant or severe bleeding manifestations within 6 months prior to enrollment. 6. Clinically significant or unstable cardiovascular diseases, including: Symptomatic myocardial ischemia or acute coronary syndrome; Uncontrolled, clinically significant cardiac arrhythmias (excluding stable, treated arrhythmias, isolated first-degree AV block, or asymptomatic bundle branch block); Congestive heart failure classified as New York Heart Association (NYHA) Class ≥ III, or known left ventricular ejection fraction (LVEF) \< 40%; Myocardial infarction within 3 months prior to Cycle 1 Day 1 (C1D1). 7. Impaired hepatic function: ALT and/or AST ≥ 2.0 ✖️ upper limit of normal (ULN); or total bilirubin ≥1.5 ✖️ ULN. 8. Severe renal impairment with CrCl \< 30mL/min or requiring renal replacement therapy. 9. Concurrent malignancy requiring active therapy or evidence of disease recurrence within 5 years prior to randomization (excluding adequately resected non-melanoma skin cancer or successfully treated cervical carcinoma in situ). 10. Major surgery within 30 days prior to study enrollment. 11. History of epilepsy, dementia, or severe psychiatric disorders that impair the patient's capacity to understand or comply with the protocol requirements. 12. Severe physical, psychiatric, or substance abuse disorder that, in the opinion of the investigator, may interfere with study participation, adherence, or outcome assessments. 13. Concurrent participation in another investigational therapeutic clinical trial. 14. Pregnant or breastfeeding women. 15. Any other medical condition, lab abnormality, or circumstance that, in the investigator's judgment, renders the participant unsuitable for enrollment.

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