Biomarkers in Multiple Myeloma
Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)
Centre Hospitalier Universitaire de Saint Etienne
70 participants
May 20, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria4
- 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.
Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05259553