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

Multiple Myeloma Clinical Trial

— METRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508416
• Other study ID #: 1108178
• Secondary ID: 2011- A01529-32
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: July 27, 2015
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
France	CHU de Clermont Ferrand	Clermont-ferrand
France	CHU de Nancy	Nancy
France	Service de Médecine Interne - CHU de Saint Etienne	Saint Etienne
France	Service de rhumatologie - CHU de Saint Etienne	Saint Etienne
France	Service d'hématologie - ICL	Saint Priest en Jarez

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Groupe de Recherche sur la Thrombose, Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 21	No
Primary	change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 42	No
Primary	change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 63	No
Primary	change from baseline in Thrombin generation measure	change from baseline in Thrombin generation measure	day 0	No
Secondary	image-confirmed venous thromboembolic events	Estimate the incidence of venous thromboembolic events until day 63	day 63	No
Secondary	change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 21	No
Secondary	change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 21	No
Secondary	change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 42	No
Secondary	change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 63	No
Secondary	change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 42	No
Secondary	change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 63	No
Secondary	change from baseline in TFPI resistance measure	change from baseline in TFPI resistance measure	day 0	No
Secondary	change from baseline in acquired protein S deficiency measure	change from baseline in acquired protein S deficiency measure	day 0	No