Actively Recruiting
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-09-25
32
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent
- Covered by a social security scheme
- Group 1: Diagnosed with de novo multiple myeloma and prescribed Apixaban for thromboprophylaxis
- Group 2: Scheduled for total knee replacement surgery and prescribed Apixaban for thromboprophylaxis
You will not qualify if you...
- Receiving curative doses of anticoagulation treatment
- Contraindication to Apixaban
- Pregnant or breastfeeding woman
- Refusal to sign consent
- Under legal protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
Research Team
E
Emilie CHALAYER, MD
CONTACT
F
Florence RANCON
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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