Multiple MyelomaPhase 4NCT07907211
Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple Myeloma
A Phase 4 study testing Aspirin and Rivaroxaban in people with Multiple Myeloma and Venous Thromboembolism (VTE), run by Chen Lijuan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Venous Thromboembolism (VTE)
- What is being tested?
- Aspirin and Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or other known acquired/congenital immunodeficiency syndromes.
- Baseline peripheral neuropathy or neuropathic pain ≥ Grade 2 according to NCI CTCAE version 5.0.
- Diagnosis of plasma cell leukemia.
- 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.
- Clinically significant or unstable cardiovascular diseases, including:
Show all 16Show fewer
- 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.
- Severe renal impairment with CrCl < 30mL/min or requiring renal replacement therapy.
- 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.
- 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.
- Concurrent participation in another investigational therapeutic clinical trial.
- Pregnant or breastfeeding women.
- Any other medical condition, lab abnormality, or circumstance that, in the investigator's judgment, renders the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Lijuan Chen, 025-68306091, chenljb@126.com
Qinglin Shi, 025-68306091, 15950520926@163.com
About this study
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
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?
Read the detailed description
This single-center, randomized, open-label, exploratory trial aims to compare the efficacy and safety of aspirin versus rivaroxaban for thromboprophylaxis in newly diagnosed multiple myeloma (NDMM) patients receiving immunomodulatory drug (IMiD)-based therapy.
A total of 200 eligible patients aged 18-70 years with measurable disease who are scheduled to receive IMiD-based chemotherapy will be randomized (1:1) to receive either aspirin 100 mg orally once daily or rivaroxaban 10 mg orally once daily for at least 6 months.
The primary endpoint is the incidence of venous thromboembolism (including deep vein thrombosis and pulmonary embolism) during the follow-up period. Secondary endpoints include safety outcomes (incidence of adverse events and bleeding episodes) and the comparative predictive performance of the IMPEDE VTE and SAVED risk assessment scores.
The trial is conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines. Findings from this study may provide clinical evidence to optimize thromboprophylaxis strategies in this high-risk hematologic population.
- Conditions
- Multiple Myeloma, Venous Thromboembolism (VTE)
- Being tested
- Aspirin, Rivaroxaban
- Keywords
- multipme myeloma, Venous thromboembolism, immunomodulatory drugs
- Medical subject headings
- Multiple Myeloma, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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.
RivaroxabanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 100 mg once daily | Active comparator | Participants receive aspirin 100 mg orally once daily as thromboprophylaxis during immunomodulatory drug (IMiD)-based therapy for at least 6 months. No other concurrent antithrombotic agents are permitted during the study treatment phase. Receives: Drug: Aspirin |
| Rivaroxaban 10 mg once daily | Experimental | Participants receive rivaroxaban 10 mg orally once daily as thromboprophylaxis during immunomodulatory drug (IMiD)-based therapy for at least 6 months. No other concurrent antithrombotic agents are permitted during the study treatment phase. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Venous Thromboembolism (VTE)
Cumulative incidence of objective venous thromboembolic events (including lower/upper extremity deep vein thrombosis and pulmonary embolism) occurring during the study period. Events will be screened through routine clinical evaluation and confirmed by compression ultrasound, CT pulmonary angiography (CTPA), or other diagnostic imaging modalities as clinically indicated.
Measured: Every 3 months during the 12-month follow-up period, and whenever clinically suspected.
Secondary outcomes (2)
Incidence of Adverse Events and Serious Adverse Events (Safety Profile)
Incidence, severity, and causal relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), with specific focus on bleeding events (classified as major bleeding, clinically relevant non-major bleeding, or minor bleeding per ISTH criteria), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: through study completion, an average of 1 year
Predictive Performance of VTE Risk Assessment Models (IMPEDE VTE and SAVED Scores)
Area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of the IMPEDE VTE score and SAVED score in predicting thrombotic risk in this patient cohort.
Measured: Assessed at baseline and correlated with VTE events over the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Lijuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Lijuan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907211
- Sponsor's protocol ID
- 2023-SR-775
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07907211
- Acronym / sponsor ID
- 2023-SR-775
- Conditions
- Multiple Myeloma, Venous Thromboembolism (VTE)
- Keywords
- multipme myeloma, Venous thromboembolism, immunomodulatory drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chen LijuanUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This single-center, randomized, open-label, exploratory trial aims to compare the efficacy and safety of aspirin versus rivaroxaban for thromboprophylaxis in newly diagnosed multiple myeloma (NDMM) patients receiving immunomodulatory drug (IMiD)-based therapy.
A total of 200 eligible patients aged 18-70 years with measurable disease who are scheduled to receive IMiD-based chemotherapy will be randomized (1:1) to receive either aspirin 100 mg orally once daily or rivaroxaban 10 mg orally once daily for at least 6 months.
The primary endpoint is the incidence of venous thromboembolism (including deep vein thrombosis and pulmonary embolism) during the follow-up period. Secondary endpoints include safety outcomes (incidence of adverse events and bleeding episodes) and the comparative predictive performance of the IMPEDE VTE and SAVED risk assessment scores.
The trial is conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines. Findings from this study may provide clinical evidence to optimize thromboprophylaxis strategies in this high-risk hematologic population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin 100 mg once daily | Active comparator | Drug: AspirinParticipants receive aspirin 100 mg orally once daily as thromboprophylaxis during immunomodulatory drug (IMiD)-based therapy for at least 6 months. No other concurrent antithrombotic agents are permitted during the study treatment phase. |
| Rivaroxaban 10 mg once daily | Experimental | Drug: RivaroxabanParticipants receive rivaroxaban 10 mg orally once daily as thromboprophylaxis during immunomodulatory drug (IMiD)-based therapy for at least 6 months. No other concurrent antithrombotic agents are permitted during the study treatment phase. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- Active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or other known acquired/congenital immunodeficiency syndromes.
- Baseline peripheral neuropathy or neuropathic pain ≥ Grade 2 according to NCI CTCAE version 5.0.
- Diagnosis of plasma cell leukemia.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin 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 | Aspirin 100 mg once daily |
| RivaroxabanRivaroxaban 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. | Drug | Rivaroxaban 10 mg once daily |
Primary outcome
Incidence of Venous Thromboembolism (VTE)
Time frame: Every 3 months during the 12-month follow-up period, and whenever clinically suspected.
Cumulative incidence of objective venous thromboembolic events (including lower/upper extremity deep vein thrombosis and pulmonary embolism) occurring during the study period. Events will be screened through routine clinical evaluation and confirmed by compression ultrasound, CT pulmonary angiography (CTPA), or other diagnostic imaging modalities as clinically indicated.
2 secondary outcomes
Incidence of Adverse Events and Serious Adverse Events (Safety Profile)
Time frame: through study completion, an average of 1 year
Predictive Performance of VTE Risk Assessment Models (IMPEDE VTE and SAVED Scores)
Time frame: Assessed at baseline and correlated with VTE events over the 12-month study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Rivaroxaban in people with Multiple Myeloma and Venous Thromboembolism (VTE), run by Chen Lijuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lijuan Chen (025-68306091, chenljb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Venous Thromboembolism (VTE) (time frame: Every 3 months during the 12-month follow-up period, and whenever clinically suspected.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.