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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01895-36 | Other Identifier | Agence Nationale de Sécurité du Médicament et des produits de santé |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with multiple myeloma | Experimental | Adult patient, over 18 years old, with newly diagnosed multiple myeloma, indication of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Other | Peripheral blood sampling will be performed at different time points of the study, for a total volume of 20-40 mL:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| 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 | 24 months |
| 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 | 24 months |
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset | Correlation between the plasma level of biomarkers and clinical data | 24 months |
| Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Chalayer, MD | Contact | 04 77 91 70 00 | +33 | emilie.chalayer@chu-st-etienne.fr |
| Elisabeth Daguenet, PhD | Contact | elisabeth.daguenet@icloire.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie Chalayer, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Recruiting | Lyon | 69495 | France |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Correlation between the plasma level of biomarkers and clinical data |
| 24 months |
| 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 | 24 months |
| Evaluation of the exposition of Apixaban (Eliquis®) | Plasma level of Apixaban in MM treated patients | 24 months |
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |