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

Recruiting now · Not applicable

Conditions studied: Multiple Myeloma, Total Knee Replacement

In brief

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.

Key facts

Study ID

NCT06474182

Run by

Centre Hospitalier Universitaire de Saint Etienne

People needed

32

Starts

2025-09-15

Expected to finish

2027-09-01

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old,
• Signed informed consent,
• Patient covered by a social security scheme.
• Group 1 : patient with a diagnosis of de novo multiple myeloma, with an indication of thromboprophylaxis with Apixaban,
• Group 2 : patient requiring a surgery for total knee replacement, , with an indication of thromboprophylaxis with Apixaban.

You may not qualify if…

• Curative doses of anticoagulation treatment,
• Contra-indication to Apixaban,
• Pregnant or breastfeeding woman,
• Refusal to sign consent,
• Patient under legal protection.

Where it is running

• CHU de Saint-Etienne — Saint-Etienne, France (enrolling)

Full record on ClinicalTrials.gov

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