Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer

Multiple Myeloma Clinical Trial

— METRO B  

Official title:

Effects of Injection Tinzaparin Prophylactic Dose (4,500 IU Anti-Xa) on Thrombin Generation in Patients With Multiple Myeloma, Lymphoma Patients and Patients Hospitalized for an Acute Medical Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260414
• Other study ID #: 1408049
• Secondary ID: 2014-000946-31
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2014
• Last updated: May 10, 2017
• Start date: April 14, 2015
• Est. completion date: May 9, 2017

Study information

• Verified date: May 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Body weight between 40 and 100 kg

2. Patient:

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:

• Patient requiring anticoagulant therapy at curative doses

• Patients with a lower platelet count 80 G / L

• Subject with a history of heparin-induced thrombocytopenia

• Subject with a history of hemorrhagic disease

• History of severe trauma within 6 weeks prior to enrollment

• Organic lesion at risk of bleeding

• Poor renal with creatinine clearance <30 ml / min

• Hypersensitivity to Tinzaparin

• Events or bleeding tendencies associated with coagulation disorders

• Subject on oral anticoagulant

• For group 3: Presence of hematological malignancy or active cancer

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Tinzaparin
single subcutaneous injection of 4500 IU tinzaparin

Other:
• Blood sample
blood sample taken at hours 0, 3, 8, 18 and 24 after subcutaneous injection of 4500 IU tinzaparin

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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