Hematological PatientsVESICOMNCT05259553
Biomarkers in Multiple Myeloma
A study testing Blood samples in people with Hematological Patients and Newly Diagnosed Multiple Myeloma, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Patients, Newly Diagnosed Multiple Myeloma, Chemotherapy
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 20 May 2022to 30 Oct 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.
Who cannot join
- Pregnant women
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refusing participation
- Patient whose follow-up or life expectancy is less than 6 months.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon
Lyon, 69495
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)
The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.
Read the detailed description
There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.
- Being tested
- Blood samples
- Keywords
- hematology, multiple myeloma, chemotherapy, thromboprophylaxis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Peripheral blood sampling will be performed at different time points of the study, for a total volume of 20-40 mL:
- Sampling before MM treatment,
- Sampling during MM treatment (at 3 months post-initiation if no autograft or before autograft),
- Only for Patients treated with Apixaban or Eliquis®, 2 additional samplings during MM treatment for pharmacokinetics analysis.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple myeloma | Experimental | Adult patient, over 18 years old, with newly diagnosed multiple myeloma, indication of chemotherapy. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of thrombin generation in newly diagnosed and untreated MM
Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Measured: 24 months
Level of factor VIII in newly diagnosed and untreated MM
Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Measured: 24 months
Level of D-Dimers in newly diagnosed and untreated MM
Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Measured: 24 months
Level of pro-coagulant phospholipids in newly diagnosed and untreated MM
Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Measured: 24 months
Secondary outcomes (4)
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset
Correlation between the plasma level of biomarkers and clinical data
Measured: 24 months
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome
Correlation between the plasma level of biomarkers and clinical data
Measured: 24 months
Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment
Correlation between the plasma level of biomarkers and clinical data
Measured: 24 months
Evaluation of the exposition of Apixaban (Eliquis®)
Plasma level of Apixaban in MM treated patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start20 May 2022
- Primary completion5 May 2025
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological PatientsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Chalayer, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259553
- Sponsor's protocol ID
- 2021-0701
- Other IDs
- 2021-A01895-36
- Acronym
- VESICOM
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2022
- Last updated
- 13 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)
- ClinicalTrials.gov ID
- NCT05259553
- Acronym / sponsor ID
- VESICOM / 2021-0701
- Keywords
- hematology, multiple myeloma, chemotherapy, thromboprophylaxis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 28 Feb 2022 (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 association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.
Detailed description
There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple myeloma | Experimental | Other: Blood samplesAdult patient, over 18 years old, with newly diagnosed multiple myeloma, indication of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.
Key exclusion criteria (4 listed)
- Pregnant women
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refusing participation
- Patient whose follow-up or life expectancy is less than 6 months.
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 |
|---|---|---|
| Blood samplesPeripheral blood sampling will be performed at different time points of the study, for a total volume of 20-40 mL: * Sampling before MM treatment, * Sampling during MM treatment (at 3 months post-initiation if no autograft or before autograft), * Only for Patients treated with Apixaban or Eliquis®, 2 additional samplings during MM treatment for pharmacokinetics analysis. | Other | Patients with multiple myeloma |
Primary outcome
Level of thrombin generation in newly diagnosed and untreated MM
Time frame: 24 months
Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of factor VIII in newly diagnosed and untreated MM
Time frame: 24 months
Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of D-Dimers in newly diagnosed and untreated MM
Time frame: 24 months
Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of pro-coagulant phospholipids in newly diagnosed and untreated MM
Time frame: 24 months
Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy
4 secondary outcomes
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset
Time frame: 24 months
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome
Time frame: 24 months
Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment
Time frame: 24 months
Evaluation of the exposition of Apixaban (Eliquis®)
Time frame: 24 months
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Emilie Chalayer, MD principal investigator
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Hematological Patients and Newly Diagnosed Multiple Myeloma, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 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 2 sites in France. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of thrombin generation in newly diagnosed and untreated MM (time frame: 24 months). The study lists 4 primary outcomes in all. 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 13 Oct 2026.