Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer

NCT ID: NCT02260414

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-14
• Study Completion Date: 2017-05-09

Brief 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.

Conditions

Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with multiple myeloma

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

Group Type: EXPERIMENTAL

Tinzaparin

Intervention Type: DRUG

single subcutaneous injection of 4500 IU tinzaparin

Blood sample

Intervention Type: OTHER

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

Patients with agressive lymphoma

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

Group Type: ACTIVE_COMPARATOR

Tinzaparin

Intervention Type: DRUG

single subcutaneous injection of 4500 IU tinzaparin

Blood sample

Intervention Type: OTHER

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

Patients with acute medical condition

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

Group Type: ACTIVE_COMPARATOR

Tinzaparin

Intervention Type: DRUG

single subcutaneous injection of 4500 IU tinzaparin

Blood sample

Intervention Type: OTHER

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

Interventions

Tinzaparin

single subcutaneous injection of 4500 IU tinzaparin

Intervention Type: DRUG

Blood sample

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard TARDY, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2014-000946-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1408049

Identifier Type: -

Identifier Source: org_study_id