Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple Myeloma

Prior treatment

• History of severe or recurrent venous/arterial thromboembolism prior to study enrollment.
• History of clinically significant or severe bleeding manifestations within 6 months prior to enrollment.
• 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).
• Major surgery within 30 days prior to study enrollment.
• Concurrent participation in another investigational therapeutic clinical trial.

Other illness

• Active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or other known acquired/congenital immunodeficiency syndromes.
• Severe renal impairment with CrCl \< 30mL/min or requiring renal replacement therapy.
• History of epilepsy, dementia, or severe psychiatric disorders that impair the patient's capacity to understand or comply with the protocol requirements.
• Severe physical, psychiatric, or substance abuse disorder that, in the opinion of the investigator, may interfere with study participation, adherence, or outcome assessments.
• Any other medical condition, lab abnormality, or circumstance that, in the investigator's judgment, renders the participant unsuitable for enrollment.

Lab values

• 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).
• Impaired hepatic function: ALT and/or AST ≥ 2.0 ✖️ upper limit of normal (ULN); or total bilirubin ≥1.5 ✖️ ULN.

Other

• Baseline peripheral neuropathy or neuropathic pain ≥ Grade 2 according to NCI CTCAE version 5.0.
• Diagnosis of plasma cell leukemia.
• Pregnant or breastfeeding women.

• Age 18 to 70 years at the time of screening.
• Newly diagnosed multiple myeloma with measurable disease according to the Chinese Guidelines for the Diagnosis and Management of Multiple Myeloma (2020 revision).
• Scheduled to receive immunomodulatory drug (thalidomide, lenalidomide, or pomalidomide)-based chemotherapy regimens.
• No clinical history or imaging evidence of venous thromboembolism at the time of initial diagnosis.
• Life expectancy \> 3 months.
• Adequate renal function defined as an endogenous creatinine clearance (CrCl) ≥30mL/min calculated by the Cockcroft-Gault formula.
• Absence of active systemic infectious disease requiring intravenous antimicrobial therapy.
• 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.
• 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.