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

Study Overview
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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.

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

Conditions
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Multiple Myeloma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Multiple Myeloma<br>Patients with newly diagnosed Multiple Myeloma required chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 21 | 
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 42 | 
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 63 | 
| change from baseline in Thrombin generation measure | change from baseline in Thrombin generation measure | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| image-confirmed venous thromboembolic events | Estimate the incidence of venous thromboembolic events until day 63 | day 63 | 
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 21 | 
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 21 | 
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 42 | 
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 63 | 
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 42 | 
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 63 | 
| change from baseline in TFPI resistance measure | change from baseline in TFPI resistance measure | day 0 | 
| change from baseline in acquired protein S deficiency measure | change from baseline in acquired protein S deficiency measure | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Newly diagnosed, Thrombin generation, TFPI, Tissue Factor pathway inhibitor, Protein S, Thrombosis, Chemotherapy