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Clinical Trials in France / NCT06474182
Recruiting Not applicable

Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

NCT06474182 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Phase
Not applicable
Started
2025-09-15
Last updated
2026-09-21

Condition(s) studied

Multiple MyelomaTotal Knee Replacement

Investigational drug(s) / intervention(s)

Blood samplingApixaban →

Blood sampling: Blood sampling

Apixaban: Treatment by Apixaban

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Saint-Etienne Saint-Etienne France Recruiting

On this site

📄 Eliquis (apixaban) drug profile →

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Other trials for the same condition

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Active, not recruiting
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE) Active, not recruiting
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma Active, not recruiting
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Recruiting
Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06474182 on ClinicalTrials.gov ↗ ← All trials in France