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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Multiple Myeloma

Patients with newly diagnosed Multiple Myeloma required chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No