Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000946-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in myeloma seems no more effective than that achieved with aspirin, while the effectiveness of the latter in the primary prevention of VTE has never been demonstrated regardless of the type of population considered. Meanwhile, a biological study showed that prophylactic doses of LMWH in patients with different types of cancer did not always optimal reduction of thrombin peak during the 24 hours following the injection of LMWH. These clinical and biological studies lead to the conclusion that patients with myeloma may be resistant to the usual doses of preventive LMWH, which may explain the failure of prevention.
Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is present in patient's biology and if this resistance is specific to myeloma in hematological cancers. For this, we propose to study the evolution of thrombin generation by Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in 6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide, lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in patients with impaired renal function, and has a greater anti-biological activity thrombotic than other LMWH.
To assess whether the observed pattern of thrombin generation is particularly multiple myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical patients hospitalized for acute heart and respiratory failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with multiple myeloma | Experimental | Patient with multiple myeloma indication with de novo standard treatment thalidomide or lenalidomide or erythropoietin treated with one injection of 4500 IU tinzaparin and blood samples taken at hours : 0, 3, 8, 18 and 24 after subcutaneous injection of tinzaparin |
|
| Patients with agressive lymphoma | Active Comparator | Patient hospitalized for aggressive lymphoma treated with chemotherapy treated with one injection of 4500 IU tinzaparin and blood samples taken at hours : 0, 3, 8, 18 and 24 after subcutaneous injection of tinzaparin |
|
| Patients with acute medical condition | Active Comparator | Patient older than 40 years and hospitalized at least three days for an acute medical pathology type of acute respiratory or cardiac treated with one injection of 4500 IU tinzaparin and blood samples taken at hours : 0, 3, 8, 18 and 24 after subcutaneous injection of tinzaparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinzaparin | Drug | single subcutaneous injection of 4500 IU tinzaparin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Thrombin Potential (ETP, nM.min) for all patients with de novo myeloma with high thrombotic risk | Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin | hours : 0, 3, 8, 18, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Thrombin Potential (ETP, nM.min) for all patients with aggressive lymphoma treated with chemotherapy | Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin | hours : 0, 3, 8, 18, 24 |
Not provided
Inclusion Criteria:
2a- With multiple myeloma indication with de novo standard treatment thalidomide or lenalidomide or erythropoietin (group 1) 2b- Or hospitalized for aggressive lymphoma treated with chemotherapy (group 2) 2c- Or older than 40 years and hospitalized at least three days for an acute medical pathology type of acute respiratory or cardiac (group 3) decompensation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernard TARDY, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood sample | Other | blood sample taken at hours 0, 3, 8, 18 and 24 after subcutaneous injection of 4500 IU tinzaparin |
|
| Endogenous Thrombin Potential (ETP, nM.min) for all patients with over 40 years hospitalized for heart or respiratory failure |
Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin |
| hours : 0, 3, 8, 18, 24 |
| Differences of Endogenous Thrombin Potential (ETP, nM.min) between group 1 and group 2 et 3 | Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin | hours : 0, 3, 8, 18, 24 |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D002241 |
| Carbohydrates |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |