Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
- Conditions
- Multiple MyelomaTotal Knee Replacement
- Interventions
- Procedure: Blood sampling
- Registration Number
- NCT06474182
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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.
- Curative doses of anticoagulation treatment,
- Contra-indication to Apixaban,
- Pregnant or breastfeeding woman,
- Refusal to sign consent,
- Patient under legal protection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blood sampling of patients with de novo multiple myeloma Apixaban Description: Blood sampling of patients with de novo multiple myeloma Blood sampling of patients undergoing total knee replacement Blood sampling Description: Blood sampling of patients undergoing total knee replacement Blood sampling of patients undergoing total knee replacement Apixaban Description: Blood sampling of patients undergoing total knee replacement Blood sampling of patients with de novo multiple myeloma Blood sampling Description: Blood sampling of patients with de novo multiple myeloma
- Primary Outcome Measures
Name Time Method Endogenous Thrombin potential (nM.min) 2 hours after Apixaban Treatment Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment
- Secondary Outcome Measures
Name Time Method Apixaban concentration (ng/mL) Kinetics of 12 hours following Apixaban treatment in both groups Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups
Pharmacodynamics' kinetics of Endogenous Thrombin Potential Kinetics of 12 hours following Apixaban treatment in both groups MidiCAT method measure : Endogenous Thrombin Potential (nM.min)
Pharmacodynamics' kinetics of Lagtime Kinetics of 12 hours following Apixaban treatment in both groups MidiCAT method measure : Lagtime (min)
Pharmacodynamics' kinetics of Time to peak Kinetics of 12 hours following Apixaban treatment in both groups MidiCAT method measure : Time to peak (min)
Pharmacodynamics' kinetics of Thrombin peak Kinetics of 12 hours following Apixaban treatment in both groups MidiCAT method measure : Thrombin peak (M, Thrombin)
Trial Locations
- Locations (1)
CHU de Saint-Etienne
🇫🇷Saint-Étienne, France