Clinical trial · Interventional
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Total Knee Replacement | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apixaban | Drug | — | UNRESOLVED |
| Blood sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Blood sampling of patients with de novo multiple myeloma
- description
- Description: Blood sampling of patients with de novo multiple myeloma
- interventionNames
- Procedure: Blood sampling
- Drug: Apixaban
- type
- EXPERIMENTAL
- label
- Blood sampling of patients undergoing total knee replacement
- description
- Description: Blood sampling of patients undergoing total knee replacement
- interventionNames
- Procedure: Blood sampling
- Drug: Apixaban
Primary outcomes (1)
- measure
- Endogenous Thrombin potential (nM.min)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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