RecruitingNot ApplicableNCT06474182

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

Comparison of the Effects of Prophylactic Administration of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma and Patients Undergoing a Surgery for Total Knee Replacement


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

32 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how apixaban (a blood-thinning medication) affects the blood clotting process in two groups: people newly diagnosed with multiple myeloma (a blood cancer) and people undergoing knee replacement surgery. Both groups are taking apixaban to prevent dangerous blood clots. Researchers want to better understand how it works in each situation. **You may be eligible if...** - You are 18 years old or older - You have newly diagnosed multiple myeloma with a recommendation to take apixaban, OR - You are having total knee replacement surgery with a recommendation to take apixaban - You are covered by a social security (health insurance) scheme **You may NOT be eligible if...** - You are already on full-dose anticoagulation (blood-thinning) treatment - You have a medical reason you cannot take apixaban - You are pregnant or breastfeeding - You are unwilling to sign the consent form - You are under legal protection Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBlood sampling

Blood sampling

DRUGApixaban

Treatment by Apixaban


Locations(1)

CHU de Saint-Etienne

Saint-Etienne, France

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NCT06474182


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