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

NCT06474182 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-25

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Blood sampling

Blood sampling

DRUG

Apixaban

Treatment by Apixaban

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Emilie CHALAYER, MD · CHU de Saint-Etienne

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06474182 on ClinicalTrials.gov