Biomarkers in Multiple Myeloma

Официальное название

Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)

Обзор

The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

Подробное описание

There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.

Вмешательства

• Другое Blood samples
  Peripheral blood sampling will be performed at different time points of the study, for a total volume of 20-40 mL: * Sampling before MM treatment, * Sampling during MM treatment (at 3 months post-initiation if no autograft or before autograft), * Only for Patients treated with Apixaban or Eliquis®, 2 additional samplings during MM treatment for pharmacokinetics analysis.

Первичные конечные точки

• Level of thrombin generation in newly diagnosed and untreated MM [Срок оценки: 24 months]
• Level of factor VIII in newly diagnosed and untreated MM [Срок оценки: 24 months]
• Level of D-Dimers in newly diagnosed and untreated MM [Срок оценки: 24 months]
• Level of pro-coagulant phospholipids in newly diagnosed and untreated MM [Срок оценки: 24 months]

Вторичные конечные точки (4)

• Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset [Срок оценки: 24 months]
• Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome [Срок оценки: 24 months]
• Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment [Срок оценки: 24 months]
• Evaluation of the exposition of Apixaban (Eliquis®) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patient affiliated to a social security regimen or beneficiary of the same
• Signed written informed consent form
• Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.

Критерии исключения

• Pregnant women
• Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
• Refusing participation
• Patient whose follow-up or life expectancy is less than 6 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 2 центра

• Hospices Civils de Lyon — Lyon
• CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT05259553 · 2021-0701 · 2021-A01895-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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