Blood samples: 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 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. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Level of thrombin generation in newly diagnosed and untreated MM — 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 — 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 — 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 — 24 months Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Trial sites (2)
Facility
City
Region
Status
Hospices Civils de Lyon
Lyon
France
Recruiting
CHU de Saint-Etienne
Saint-Etienne
France
Recruiting
More Centre Hospitalier Universitaire de Saint Etienne trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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