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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2024-A00769-38 |
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Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood sampling of patients with de novo multiple myeloma | Experimental | Description: Blood sampling of patients with de novo multiple myeloma |
|
| Blood sampling of patients undergoing total knee replacement | Experimental | Description: Blood sampling of patients undergoing total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Thrombin potential (nM.min) | Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment | 2 hours after Apixaban Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Apixaban concentration (ng/mL) | Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups | Kinetics of 12 hours following Apixaban treatment in both groups |
| Pharmacodynamics' kinetics of Endogenous Thrombin Potential |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie CHALAYER, MD | Contact | (0)477822814 | 33 | emilie.chalayer@chu-st-etienne.fr |
| Florence RANCON | Contact | (0)4 77 82 94 58 | 33 | florence.rancon@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie CHALAYER, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | 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 |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Apixaban | Drug | Treatment by Apixaban |
|
MidiCAT method measure : Endogenous Thrombin Potential (nM.min) |
| Kinetics of 12 hours following Apixaban treatment in both groups |
| Pharmacodynamics' kinetics of Lagtime | MidiCAT method measure : Lagtime (min) | Kinetics of 12 hours following Apixaban treatment in both groups |
| Pharmacodynamics' kinetics of Time to peak | MidiCAT method measure : Time to peak (min) | Kinetics of 12 hours following Apixaban treatment in both groups |
| Pharmacodynamics' kinetics of Thrombin peak | MidiCAT method measure : Thrombin peak (M, Thrombin) | Kinetics of 12 hours following Apixaban treatment in both groups |
| 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 |