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

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ClinicalTrials.gov Identifier: NCT01508416
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : July 28, 2015
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

Brief Summary:

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 or disease
Multiple Myeloma

Study Type : Observational
Actual Enrollment : 71 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Group/Cohort
Patients with Multiple Myeloma
Patients with newly diagnosed Multiple Myeloma required chemotherapy



Primary Outcome Measures :
  1. change from baseline in Thrombin generation measure [ Time Frame: day 21 ]
    change from baseline in Thrombin generation measure

  2. change from baseline in Thrombin generation measure [ Time Frame: day 42 ]
    change from baseline in Thrombin generation measure

  3. change from baseline in Thrombin generation measure [ Time Frame: day 63 ]
    change from baseline in Thrombin generation measure

  4. change from baseline in Thrombin generation measure [ Time Frame: day 0 ]
    change from baseline in Thrombin generation measure


Secondary Outcome Measures :
  1. image-confirmed venous thromboembolic events [ Time Frame: day 63 ]
    Estimate the incidence of venous thromboembolic events until day 63

  2. change from baseline in TFPI resistance measure [ Time Frame: day 21 ]
    change from baseline in TFPI resistance measure

  3. change from baseline in acquired protein S deficiency measure [ Time Frame: day 21 ]
    change from baseline in acquired protein S deficiency measure

  4. change from baseline in TFPI resistance measure [ Time Frame: day 42 ]
    change from baseline in TFPI resistance measure

  5. change from baseline in TFPI resistance measure [ Time Frame: day 63 ]
    change from baseline in TFPI resistance measure

  6. change from baseline in acquired protein S deficiency measure [ Time Frame: day 42 ]
    change from baseline in acquired protein S deficiency measure

  7. change from baseline in acquired protein S deficiency measure [ Time Frame: day 63 ]
    change from baseline in acquired protein S deficiency measure

  8. change from baseline in TFPI resistance measure [ Time Frame: day 0 ]
    change from baseline in TFPI resistance measure

  9. change from baseline in acquired protein S deficiency measure [ Time Frame: day 0 ]
    change from baseline in acquired protein S deficiency measure


Biospecimen Retention:   Samples Without DNA
whole blood and serum


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01508416     History of Changes
Other Study ID Numbers: 1108178
2011- A01529-32 ( Other Identifier: Afssaps )
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

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
Hemostatics
Coagulants