Biomarkers in Multiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Blood samples
Other interventionPeripheral 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Patients with multiple myelomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 months2
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
Time frame
24 months3
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
Time frame
24 months4
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
Time frame
24 monthsSecondary outcomes
1
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset
Correlation between the plasma level of biomarkers and clinical data
Time frame
24 months2
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome
Correlation between the plasma level of biomarkers and clinical data
Time frame
24 months3
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
Time frame
24 months4
Evaluation of the exposition of Apixaban (Eliquis®)
Plasma level of Apixaban in MM treated patients
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov