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NCT Number: NCT01508416

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Groupe de Recherche sur la Thrombose
  • Institut de Cancérologie de la Loire

Registry information

Official study title

Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study

Acronym: METRO

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 12, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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