Aspirin or rivaroxaban to prevent blood clots in newly diagnosed multiple myeloma
Compares aspirin with rivaroxaban for preventing blood clots in people with multiple myeloma.
Plain-language title generated from the registry record
Registry title: Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple Myeloma
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07907211, who can take part
Where in China
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chen Lijuan
- Trial code
- NCT07907211
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A Single-Center, Randomized Clinical Trial of Aspirin Versus Rivaroxaban for Thromboprophylaxis in Newly Diagnosed Multiple Myeloma Patients Receiving Immunomodulatory Agent-Based Therapy
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?
Inclusion: 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.
Exclusion: 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; 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; 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; Baseline peripheral neuropathy or neuropathic pain ≥ Grade 2 according to NCI CTCAE version 5.0; Diagnosis of plasma cell leukemia; Pregnant or breastfeeding women.