Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011- A01529-32 | Other Identifier | Afssaps |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut de Cancérologie de la Loire | OTHER |
| Groupe de Recherche sur la Thrombose | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy.
Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk.
The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Multiple Myeloma | Patients with newly diagnosed Multiple Myeloma required chemotherapy |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 21 |
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 42 |
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 63 |
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| image-confirmed venous thromboembolic events | Estimate the incidence of venous thromboembolic events until day 63 | day 63 |
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with newly diagnosed Multiple Myeloma required chemotherapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernard TARDY, MD-PhD | CHU de Saint-Etienne - CIC-EC (CIE3) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont Ferrand | Clermont-Ferrand | 63000 | France | |||
| CHU de Nancy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39823789 | Derived | Charles S, Fatrara T, Bouriche T, Bonifay A, Lecompte T, Dignat-George F, Tardy B, Frere C, Lacroix R, Chalayer E. Tissue factor-bearing extracellular vesicles, procoagulant phospholipids and D-dimer as potential biomarkers for venous thromboembolism in patients with newly diagnosed multiple myeloma: A comprehensive analysis. Thromb Res. 2025 Mar;247:109256. doi: 10.1016/j.thromres.2025.109256. Epub 2025 Jan 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood and serum
| day 21 |
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 21 |
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 42 |
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 63 |
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 42 |
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 63 |
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 0 |
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 0 |
| Nancy |
| 54000 |
| France |
| Service de Médecine Interne - CHU de Saint Etienne | Saint-Etienne | 42055 | France |
| Service de rhumatologie - CHU de Saint Etienne | Saint-Etienne | 42055 | France |
| Service d'hématologie - ICL | Saint-Priest-en-Jarez | 42270 | 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 |
| D016769 | Embolism and Thrombosis |