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

This study has been completed.
Sponsor:
Collaborators:
Institut de Cancérologie de la Loire
Groupe de Recherche sur la Thrombose
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01508416
First received: December 15, 2011
Last updated: July 27, 2015
Last verified: July 2015
  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


Enrollment: 71
Study Start Date: January 2012
Study Completion Date: June 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508416

Locations
France
CHU de Clermont Ferrand
Clermont-ferrand, France, 63000
CHU de Nancy
Nancy, France, 54000
Service de Médecine Interne - CHU de Saint Etienne
Saint Etienne, France, 42055
Service de rhumatologie - CHU de Saint Etienne
Saint Etienne, France, 42055
Service d'hématologie - ICL
Saint Priest en Jarez, France, 42270
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Institut de Cancérologie de la Loire
Groupe de Recherche sur la Thrombose
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: July 27, 2015
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Thrombin
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015