Chemotherapy, Hematological Patients, Newly Diagnosed Multiple Myeloma
Conditions
Keywords
hematology, multiple myeloma, chemotherapy, thromboprophylaxis
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.
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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset | 24 months | Correlation between the plasma level of biomarkers and clinical data |
| Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome | 24 months | Correlation between the plasma level of biomarkers and clinical data |
| Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment | 24 months | Correlation between the plasma level of biomarkers and clinical data |
| Evaluation of the exposition of Apixaban (Eliquis®) | 24 months | Plasma level of Apixaban in MM treated patients |
Countries
France
Contacts
Primary ContactEmilie Chalayer, MD
Backup ContactElisabeth Daguenet, PhD
Outcome results
None listed