Apixaban for Multiple myeloma|Total knee replacement|Thromboembolism prophylaxis

Inclusion criteria

• {"criterion_text":"- Patient over 18 years of age."}
• {"criterion_text":"- Signed informed consent."}
• {"criterion_text":"- Patient covered by a social security scheme."}
• {"criterion_text":"- Group 1 (MM): Patient suffering from de novo multiple myeloma for whom treatment including thromboprophylaxis with apixaban is recommended."}
• {"criterion_text":"- Group 2 (PTG): Patient undergoing knee joint replacement with a total prosthesis for whom thromboprophylaxis with apixaban is recommended."}

Exclusion criteria

• {"criterion_text":"- Indication for curative anticoagulant treatment."}
• {"criterion_text":"- Contraindication to the use of apixaban."}
• {"criterion_text":"- Pregnant or breast-feeding woman."}
• {"criterion_text":"- Refusal to sign the consent form."}
• {"criterion_text":"- Protected adult patient."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the endogenous thrombin potential (ETP) measured by thrombinography using the MidiCAT method at peak concentration after administration of a 2.5mg dose in patients treated for de novo multiple myeloma (group 1) or operated on for total knee replacement (group 2) with a sample taken 2 hours after the first dose of ‘Apixaban’. ETP is expressed as the concentration of active thrombin multiplied by time (nM.min).","definition_or_measurement_approach":"ETP measured by thrombinography using the MidiCAT method at peak concentration (sample taken 2 hours after first 2.5 mg dose). ETP expressed as concentration of active thrombin multiplied by time (nM.min)."}

Secondary endpoints

• {"endpoint_text":"- Measurement of Apixaban concentration (in ng/mL) by mass spectrometry during the 12 hours following administration of a dose of Apixaban 2.5mg in both groups.","definition_or_measurement_approach":"Apixaban concentration measured (ng/mL) by mass spectrometry over 12 hours following 2.5 mg dose."}
• {"endpoint_text":"- Evaluation of the pharmacodynamic evolution kinetics of thrombin generation (using the parameters ETP (nM/min), Lagtime (min), Time to peak (min), Thrombin peak (M Thrombin) in the presence and absence of thrombomodulin in both groups at H0, H2, H6 and H12 of Apixaban administration using the MidiCAT method.","definition_or_measurement_approach":"Thrombin generation kinetics assessed by MidiCAT method at H0, H2, H6, H12; parameters: ETP (nM/min), Lagtime (min), Time to peak (min), Thrombin peak (M Thrombin) measured in presence and absence of thrombomodulin."}
• {"endpoint_text":"- Modelling of the pharmacokinetic-pharmacodynamic relationship in each group.","definition_or_measurement_approach":"PK-PD modelling based on measured apixaban concentrations and thrombin generation parameters in each group."}
• {"endpoint_text":"- Evaluation of changes in pharmacokinetics (Apixaban dosage in ng/mL) and pharmacodynamics (thrombin generation using the MidiCAT method) after 5 cycles of chemotherapy +/- 1 cycle for patients in group 1.","definition_or_measurement_approach":"Comparison of apixaban concentration (ng/mL) and thrombin generation (MidiCAT) at baseline and after 5 cycles of chemotherapy +/-1 cycle in group 1."}

France

Latest Decision Or Authorization Date

14-05-2025

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Saint Etienne

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France