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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 August 2012 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: August 7, 2012
Last verified: August 2012
History of Changes

December 15, 2011
August 7, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01508416 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood and serum
Non-Probability Sample

Patients with newly diagnosed Multiple Myeloma required chemotherapy
Multiple Myeloma
Not Provided
Patients with Multiple Myeloma
Patients with newly diagnosed Multiple Myeloma required chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Arnauld GARCIN, CRA +33(4)77120286 agarcin34@yahoo.fr
France
 
NCT01508416
1108178, 2011- A01529-32
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
  • Institut de Cancérologie de la Loire
  • Groupe de Recherche sur la Thrombose (GRT)
Principal Investigator: Bernard TARDY, MD-PhD CHU de Saint-Etienne - CIC-EC (CIE3)
Centre Hospitalier Universitaire de Saint Etienne
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP