NCT02260414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 14, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

October 2, 2014

Last Update Submit

May 10, 2017

Conditions

LymphomaMultiple Myeloma

Keywords

Endogenous Thrombin PotentialLymphomaMultiple Myelomatinzaparinthrombin generationThromboplastin generation tests

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Endogenous Thrombin Potential (ETP, nM.min) for all patients with aggressive lymphoma treated with chemotherapy

    hours : 0, 3, 8, 18, 24

  • Endogenous Thrombin Potential (ETP, nM.min) for all patients with over 40 years hospitalized for heart or respiratory failure

    hours : 0, 3, 8, 18, 24

  • Differences of Endogenous Thrombin Potential (ETP, nM.min) between group 1 and group 2 et 3

    hours : 0, 3, 8, 18, 24

Study Arms (3)

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

Drug: TinzaparinOther: Blood sample

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

Drug: TinzaparinOther: Blood sample

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

Drug: TinzaparinOther: Blood sample

Interventions

TinzaparinDRUG

single subcutaneous injection of 4500 IU tinzaparin

Patients with acute medical conditionPatients with agressive lymphomaPatients with multiple myeloma
Blood sampleOTHER

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

Patients with acute medical conditionPatients with agressive lymphomaPatients with multiple myeloma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body weight between 40 and 100 kg
  • Patient:
  • a- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Interventions

TinzaparinBlood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Bernard TARDY, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 9, 2014

Study Start

April 14, 2015

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

FR(1)