Clinical trial NCT06474182: Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Total Knee Replacement
Keywords: Multiple myeloma
thromboprophylaxis
pharmacodynamics
coagulability
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Endogenous Thrombin potential (nM.min)
timeFrame: 2 hours after Apixaban Treatment
Secondary outcomes:
measure: Apixaban concentration (ng/mL)
timeFrame: Kinetics of 12 hours following Apixaban treatment in both groups
measure: Pharmacodynamics' kinetics of Endogenous Thrombin Potential
timeFrame: Kinetics of 12 hours following Apixaban treatment in both groups
measure: Pharmacodynamics' kinetics of Lagtime
timeFrame: Kinetics of 12 hours following Apixaban treatment in both groups
measure: Pharmacodynamics' kinetics of Time to peak
timeFrame: Kinetics of 12 hours following Apixaban treatment in both groups
measure: Pharmacodynamics' kinetics of Thrombin peak
timeFrame: Kinetics of 12 hours following Apixaban treatment in both groups
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Emilie CHALAYER, MD
role: PRINCIPAL_INVESTIGATOR
References: