Clinical trial NCT05259553: Biomarkers in Multiple Myeloma
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematological Patients
Newly Diagnosed Multiple Myeloma
Chemotherapy
Keywords: hematology
multiple myeloma
chemotherapy
thromboprophylaxis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Level of thrombin generation in newly diagnosed and untreated MM
timeFrame: 24 months
measure: Level of factor VIII in newly diagnosed and untreated MM
timeFrame: 24 months
measure: Level of D-Dimers in newly diagnosed and untreated MM
timeFrame: 24 months
measure: Level of pro-coagulant phospholipids in newly diagnosed and untreated MM
timeFrame: 24 months
Secondary outcomes:
measure: Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset
timeFrame: 24 months
measure: Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome
timeFrame: 24 months
measure: Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment
timeFrame: 24 months
measure: Evaluation of the exposition of Apixaban (Eliquis®)
timeFrame: 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Emilie Chalayer, MD
role: PRINCIPAL_INVESTIGATOR
References: