Clinical trial NCT01508416: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma
Official title: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Newly diagnosed
Thrombin generation
TFPI
Tissue Factor pathway inhibitor
Protein S
Thrombosis
Chemotherapy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de la Loire
name: Groupe de Recherche sur la Thrombose
First posted: 2012-01-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed Multiple Myeloma required chemotherapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in Thrombin generation measure
timeFrame: day 21
measure: change from baseline in Thrombin generation measure
timeFrame: day 42
measure: change from baseline in Thrombin generation measure
timeFrame: day 63
measure: change from baseline in Thrombin generation measure
timeFrame: day 0
Secondary outcomes:
measure: image-confirmed venous thromboembolic events
timeFrame: day 63
measure: change from baseline in TFPI resistance measure
timeFrame: day 21
measure: change from baseline in acquired protein S deficiency measure
timeFrame: day 21
measure: change from baseline in TFPI resistance measure
timeFrame: day 42
measure: change from baseline in TFPI resistance measure
timeFrame: day 63
measure: change from baseline in acquired protein S deficiency measure
timeFrame: day 42
measure: change from baseline in acquired protein S deficiency measure
timeFrame: day 63
measure: change from baseline in TFPI resistance measure
timeFrame: day 0
measure: change from baseline in acquired protein S deficiency measure
timeFrame: day 0
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU de Clermont Ferrand
city: Nancy
country: France
facility: CHU de Nancy
city: Saint Etienne
country: France
facility: Service de Médecine Interne - CHU de Saint Etienne
city: Saint Etienne
country: France
facility: Service de rhumatologie - CHU de Saint Etienne
city: Saint Priest en Jarez
country: France
facility: Service d'hématologie - ICL
Study officials:
affiliation: CHU de Saint-Etienne - CIC-EC (CIE3)
name: Bernard TARDY, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: