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

What this Trial Is About

Researchers are investigating the link between multiple myeloma (MM) and venous thromboembolism (VTE), focusing on identifying predictive biomarkers for VTE risk in patients newly diagnosed with MM. The study also examines how treatments for MM, especially immunomodulatory drugs combined with glucocorticoids, may increase VTE risk and affect clinical outcomes. The goal is to improve thromboprophylaxis decisions by understanding blood clotting factors and potential drug interactions in MM therapy. The study involves collecting blood samples from adults over 18 with newly diagnosed multiple myeloma before and during chemotherapy treatment. Blood is drawn at multiple points: before starting treatment, three months after treatment begins (or before autograft), and additional samples for pharmacokinetics analysis in patients treated with Apixaban (Eliquis4). These tests measure levels of thrombin generation, factor VIII, D-Dimers, and pro-coagulant phospholipids to evaluate their role as biomarkers. Participants will undergo blood sampling and monitoring over 24 months to track changes in coagulation markers and their association with VTE and MM outcomes. The study evaluates the exposure to Apixaban in relevant patients and documents the evolution of biomarkers three months post-treatment. The research team will assess how these factors impact the risk of thrombosis and clinical progression in MM, aiming to optimize thromboprophylaxis and treatment safety.

Biomarkers in Multiple Myeloma