Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling, Apixaban.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Total Knee Replacement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Procedure Blood sampling
Blood sampling - Drug Apixaban
Treatment by Apixaban
Primary outcome measures
- Endogenous Thrombin potential (nM.min) [Time frame: 2 hours after Apixaban Treatment]
Secondary outcome measures (5)
- Apixaban concentration (ng/mL) [Time frame: Kinetics of 12 hours following Apixaban treatment in both groups]
- Pharmacodynamics' kinetics of Endogenous Thrombin Potential [Time frame: Kinetics of 12 hours following Apixaban treatment in both groups]
- Pharmacodynamics' kinetics of Lagtime [Time frame: Kinetics of 12 hours following Apixaban treatment in both groups]
- Pharmacodynamics' kinetics of Time to peak [Time frame: Kinetics of 12 hours following Apixaban treatment in both groups]
- Pharmacodynamics' kinetics of Thrombin peak [Time frame: Kinetics of 12 hours following Apixaban treatment in both groups]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT06474182 · 23CH293 · ANSM