Apixaban's effect on blood clotting in newly diagnosed multiple myeloma
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
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT06474182
This test sees if apixaban lowers blood clotting more in people with newly diagnosed multiple myeloma than in people taking apixaban after knee replacement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT06474182 on ClinicalTrials.gov |
What this trial studies
This study compares blood clotting activity and apixaban plasma levels between two groups: patients with de novo multiple myeloma receiving prophylactic apixaban and patients receiving apixaban after total knee replacement. Investigators collect timed blood samples to measure apixaban concentration and thrombin generation (coagulability) assays. The protocol examines whether pharmacokinetic differences in myeloma plasma translate into greater reductions in thrombin generation. Findings may indicate whether thromboprophylaxis dosing or monitoring should be adjusted for multiple myeloma patients.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed multiple myeloma who require apixaban prophylaxis, and adults undergoing total knee replacement who will receive apixaban, who can provide informed consent and attend blood draws.
Not a fit: Patients on full therapeutic anticoagulation, those with contraindications to apixaban, pregnant or breastfeeding women, or people unable to consent are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help tailor apixaban thromboprophylaxis to reduce clotting and bleeding risks in multiple myeloma patients.
How similar studies have performed: Prior trials like AVERT have shown apixaban prevents VTE in cancer patients and the APIXABOR ancillary work found higher apixaban peaks in myeloma plasma, but direct pharmacodynamic comparisons of coagulability in myeloma versus surgical patients are novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint-Etienne
- CHU de Saint-Etienne — Saint-Etienne, France (RECRUITING)
Study contacts
- Principal investigator: Emilie CHALAYER, MD — CHU de Saint-Etienne
- Study coordinator: Emilie CHALAYER, MD
- Email: emilie.chalayer@chu-st-etienne.fr
- Phone: (0)477822814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Total Knee Replacement, Multiple myeloma, thromboprophylaxis, pharmacodynamics, coagulability