Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (METRO)

This study is currently recruiting participants.
Verified February 2014 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborators:
Institut de Cancérologie de la Loire
Groupe de Recherche sur la Thrombose (GRT)
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01508416
First received: December 15, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy.

Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk.

The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.


Condition
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • change from baseline in Thrombin generation measure [ Time Frame: day 21 ] [ Designated as safety issue: No ]
    change from baseline in Thrombin generation measure

  • change from baseline in Thrombin generation measure [ Time Frame: day 42 ] [ Designated as safety issue: No ]
    change from baseline in Thrombin generation measure

  • change from baseline in Thrombin generation measure [ Time Frame: day 63 ] [ Designated as safety issue: No ]
    change from baseline in Thrombin generation measure

  • change from baseline in Thrombin generation measure [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    change from baseline in Thrombin generation measure


Secondary Outcome Measures:
  • image-confirmed venous thromboembolic events [ Time Frame: day 63 ] [ Designated as safety issue: No ]
    Estimate the incidence of venous thromboembolic events until day 63

  • change from baseline in TFPI resistance measure [ Time Frame: day 21 ] [ Designated as safety issue: No ]
    change from baseline in TFPI resistance measure

  • change from baseline in acquired protein S deficiency measure [ Time Frame: day 21 ] [ Designated as safety issue: No ]
    change from baseline in acquired protein S deficiency measure

  • change from baseline in TFPI resistance measure [ Time Frame: day 42 ] [ Designated as safety issue: No ]
    change from baseline in TFPI resistance measure

  • change from baseline in TFPI resistance measure [ Time Frame: day 63 ] [ Designated as safety issue: No ]
    change from baseline in TFPI resistance measure

  • change from baseline in acquired protein S deficiency measure [ Time Frame: day 42 ] [ Designated as safety issue: No ]
    change from baseline in acquired protein S deficiency measure

  • change from baseline in acquired protein S deficiency measure [ Time Frame: day 63 ] [ Designated as safety issue: No ]
    change from baseline in acquired protein S deficiency measure

  • change from baseline in TFPI resistance measure [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    change from baseline in TFPI resistance measure

  • change from baseline in acquired protein S deficiency measure [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    change from baseline in acquired protein S deficiency measure


Biospecimen Retention:   Samples Without DNA

whole blood and serum


Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Multiple Myeloma
Patients with newly diagnosed Multiple Myeloma required chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with newly diagnosed Multiple Myeloma required chemotherapy

Criteria

Inclusion Criteria:

  • Inscription to medical assurance
  • Patients who gave their written consent
  • Patients with newly diagnosed Multiple Myeloma required chemotherapy

Exclusion Criteria:

  • Patients with renal failure who need to undergo hemodialysis
  • Patients with indication for curative anticoagulant therapy
  • Patient with 3 month follow-up not possible
  • Patient with life expectancy < 6 month
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508416

Contacts
Contact: Madjid AKROUR, CRA +33(4)77127837 madjid.akrour@chu-st-etienne.fr

Locations
France
CHU de Clermont Ferrand Recruiting
Clermont-ferrand, France, 63000
Principal Investigator: Jacques Olivier BAY, MD PhD         
Sub-Investigator: Benoit de RANZIS, MD         
Sub-Investigator: Carine CHATELEIX, MD         
Sub-Investigator: Cécile MONTLUCON-CHABROT, MD         
Sub-Investigator: Eric HERMET, MD         
Sub-Investigator: Olivier TOURNILHAC, MD         
Sub-Investigator: Laure CALVET, MD         
Sub-Investigator: Romain GUIEZE, MD         
Sub-Investigator: Victoria CACHEUX, MD         
CHU de Nancy Recruiting
Nancy, France, 54000
Principal Investigator: Cyrille HULIN, MD         
Service de rhumatologie - CHU de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Philippe Collet, MD         
Principal Investigator: Philippe Collet, MD         
Service de Médecine Interne - CHU de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Pascal Cathebras, PHD         
Principal Investigator: Pascal Cathebras, PHD         
Sub-Investigator: Jean Baptiste Gaultier, MD         
Service d'hématologie - ICL Recruiting
Saint Priest en Jarez, France, 42270
Contact: Denis Guyotat, PHD         
Principal Investigator: Denis Guyotat, MD-PhD         
Sub-Investigator: Jérome Jaubert, MD         
Sub-Investigator: Karine Augeul Meunier, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Institut de Cancérologie de la Loire
Groupe de Recherche sur la Thrombose (GRT)
Investigators
Principal Investigator: Bernard TARDY, MD-PhD CHU de Saint-Etienne - CIC-EC (CIE3)
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01508416     History of Changes
Other Study ID Numbers: 1108178, 2011- A01529-32
Study First Received: December 15, 2011
Last Updated: February 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Multiple Myeloma
Newly diagnosed
Thrombin generation
TFPI
Tissue Factor pathway inhibitor
Protein S
Thrombosis
Chemotherapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thrombin
Lipoprotein-associated coagulation inhibitor
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014