RecruitingNot ApplicableNCT05259553

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)


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

70 participants

Start Date

May 20, 2022

Study Type

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

Min Age: 18 Years

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

OTHERBlood 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.


Locations(2)

Hospices Civils de Lyon

Lyon, France

CHU de Saint-Etienne

Saint-Etienne, France

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NCT05259553


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