NCT06474182 Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
| NCT ID | NCT06474182 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-09-15 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Emilie CHALAYER, MD
PRINCIPAL INVESTIGATOR
CHU de Saint-Etienne
Frequently Asked Questions
Who can join the NCT06474182 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06474182 currently recruiting?
Yes, NCT06474182 is actively recruiting participants. Contact the research team at emilie.chalayer@chu-st-etienne.fr for enrollment information.
Where is the NCT06474182 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT06474182 clinical trial?
NCT06474182 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Emilie CHALAYER, MD at CHU de Saint-Etienne. The trial plans to enroll 32 participants.