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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01508416

Acronym

METRO

Enrollment

Registered

2012-01-12

Start date

2012-01-31

Completion date

2015-06-30

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Newly diagnosed, Thrombin generation, TFPI, Tissue Factor pathway inhibitor, Protein S, Thrombosis, 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change from baseline in Thrombin generation measure	day 21	change from baseline in Thrombin generation measure

Secondary

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

Countries

France

Outcome results