search
Back to results

Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer (METRO B)

Primary Purpose

Lymphoma, Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tinzaparin
Blood sample
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lymphoma focused on measuring Endogenous Thrombin Potential, Lymphoma, Multiple Myeloma, tinzaparin, thrombin generation, Thromboplastin generation tests

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Patients with multiple myeloma

Patients with agressive lymphoma

Patients with acute medical condition

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
October 2, 2014
Last Updated
May 10, 2017
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
LEO Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT02260414
Brief Title
Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 14, 2015 (Actual)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma
Keywords
Endogenous Thrombin Potential, Lymphoma, Multiple Myeloma, tinzaparin, thrombin generation, Thromboplastin generation tests

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with multiple myeloma
Arm Type
Experimental
Arm Description
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
Arm Title
Patients with agressive lymphoma
Arm Type
Active Comparator
Arm Description
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
Arm Title
Patients with acute medical condition
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tinzaparin
Intervention Description
single subcutaneous injection of 4500 IU tinzaparin
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
blood sample taken at hours 0, 3, 8, 18 and 24 after subcutaneous injection of 4500 IU tinzaparin
Primary Outcome Measure Information:
Title
Endogenous Thrombin Potential (ETP, nM.min) for all patients with de novo myeloma with high thrombotic risk
Description
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
Time Frame
hours : 0, 3, 8, 18, 24
Secondary Outcome Measure Information:
Title
Endogenous Thrombin Potential (ETP, nM.min) for all patients with aggressive lymphoma treated with chemotherapy
Description
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
Time Frame
hours : 0, 3, 8, 18, 24
Title
Endogenous Thrombin Potential (ETP, nM.min) for all patients with over 40 years hospitalized for heart or respiratory failure
Description
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
Time Frame
hours : 0, 3, 8, 18, 24
Title
Differences of Endogenous Thrombin Potential (ETP, nM.min) between group 1 and group 2 et 3
Description
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
Time Frame
hours : 0, 3, 8, 18, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body weight between 40 and 100 kg 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard TARDY, PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Learn more about this trial

Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer

We'll reach out to this number within 24 hrs