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

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT01508416
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change from baseline in Thrombin generation measure	day 0	change from baseline in Thrombin generation measure

Secondary Outcome Measures

Name	Time	Method
change from baseline in TFPI resistance measure	day 0	change from baseline in TFPI resistance measure
change from baseline in acquired protein S deficiency measure	day 0	change from baseline in acquired protein S deficiency measure
image-confirmed venous thromboembolic events	day 63	Estimate the incidence of venous thromboembolic events until day 63

Trial Locations

Locations (5)

CHU de Nancy; 🇫🇷 Nancy, France

Service de Médecine Interne - CHU de Saint Etienne; 🇫🇷 Saint Etienne, France

Service d'hématologie - ICL; 🇫🇷 Saint Priest en Jarez, France

CHU de Clermont Ferrand; 🇫🇷 Clermont-ferrand, France

Service de rhumatologie - CHU de Saint Etienne; 🇫🇷 Saint Etienne, France