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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • CHU de Clermont Ferrand
  • Nancy, France, 54000
    • Chu de Nancy
  • Saint Etienne, France, 42055
    • Service de Médecine Interne - CHU de Saint Etienne
  • Saint Etienne, France, 42055
    • Service de rhumatologie - CHU de Saint Etienne
  • Saint Priest en Jarez, France, 42270
    • Service d'hématologie - ICL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed Multiple Myeloma required chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 21
change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 42
change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 63
change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image-confirmed venous thromboembolic events	Estimate the incidence of venous thromboembolic events until day 63	day 63
change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 21
change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 21
change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 42
change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 63
change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 42
change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 63
change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 0
change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: 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)

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Thrombosis; Chemotherapy; Newly diagnosed; Thrombin generation; TFPI; Tissue Factor pathway inhibitor; Protein S
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 1108178; 2011- A01529-32 (Other Identifier: Afssaps)