drugset / Trial / NCT06474182

Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

NCT06474182

Recruiting 32 enrolled University Hospital of Saint-Etienne
Non-randomizedParallel-groupSingle-blindOther

Summary

Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.

Timeline

Start
2025-09-15
Primary completion
2027-03
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule

Indications