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Trial Title:
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
NCT ID:
NCT06474182
Condition:
Multiple Myeloma
Total Knee Replacement
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Apixaban
Conditions: Keywords:
Multiple myeloma
thromboprophylaxis
pharmacodynamics
coagulability
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Blood sampling
Description:
Blood sampling
Arm group label:
Blood sampling of patients undergoing total knee replacement
Arm group label:
Blood sampling of patients with de novo multiple myeloma
Intervention type:
Drug
Intervention name:
Apixaban
Description:
Treatment by Apixaban
Arm group label:
Blood sampling of patients undergoing total knee replacement
Arm group label:
Blood sampling of patients with de novo multiple myeloma
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Saint-Etienne
Address:
City:
Saint-Étienne
Zip:
42055
Country:
France
Contact:
Last name:
Emilie CHALAYER, MD
Phone:
(0)4 77 82 28 14
Phone ext:
33
Email:
emilie.chalayer@chu-st-etienne.fr
Investigator:
Last name:
Jean-Yves BIEN, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jérôme CORNILLON, MD
Email:
Sub-Investigator
Investigator:
Last name:
Charlotte DOUBLET, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ludovic FOUILLET, MD
Email:
Sub-Investigator
Investigator:
Last name:
Julien LANOISELEE, MD
Email:
Sub-Investigator
Investigator:
Last name:
Tiphany NEEL, MD
Email:
Sub-Investigator
Investigator:
Last name:
Manon SAPET, MD
Email:
Sub-Investigator
Investigator:
Last name:
Emmanuelle TAVERNIER, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hugo THEVENET, MD
Email:
Sub-Investigator
Start date:
October 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Saint Etienne
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Saint Etienne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06474182
