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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Emilie CHALAYER, MD
emilie.chalayer@chu-st-etienne.fr
(0)477822814
Backup
Florence RANCON
florence.rancon@chu-st-etienne.fr
(0)4 77 82 94 58
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-09
Participants
Target number of participants: 32
Treatments
Experimental: Blood sampling of patients with de novo multiple myeloma
Description: Blood sampling of patients with de novo multiple myeloma
Experimental: Blood sampling of patients undergoing total knee replacement
Description: Blood sampling of patients undergoing total knee replacement
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov

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