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

September 24, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Recruiting
        • CHU de Saint-Etienne
        • Sub-Investigator:
          • Julien LANOISELEE, MD
        • Sub-Investigator:
          • Ludovic FOUILLET, MD
        • Sub-Investigator:
          • Jean-Yves BIEN, MD
        • Sub-Investigator:
          • Emmanuelle TAVERNIER, MD
        • Contact:
        • Sub-Investigator:
          • Jérôme CORNILLON, MD
        • Sub-Investigator:
          • Charlotte DOUBLET, MD
        • Sub-Investigator:
          • Tiphany NEEL, MD
        • Sub-Investigator:
          • Manon SAPET, MD
        • Sub-Investigator:
          • Hugo THEVENET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood sampling of patients with de novo multiple myeloma
Description: Blood sampling of patients with de novo multiple myeloma
Procedure: Blood sampling
Blood sampling
Drug: Apixaban
Treatment by Apixaban
Experimental: Blood sampling of patients undergoing total knee replacement
Description: Blood sampling of patients undergoing total knee replacement
Procedure: Blood sampling
Blood sampling
Drug: Apixaban
Treatment by Apixaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endogenous Thrombin potential (nM.min)
Time Frame: 2 hours after Apixaban Treatment
Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment
2 hours after Apixaban Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apixaban concentration (ng/mL)
Time Frame: Kinetics of 12 hours following Apixaban treatment in both groups
Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups
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
MidiCAT method measure : Endogenous Thrombin Potential (nM.min)
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
MidiCAT method measure : Lagtime (min)
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
MidiCAT method measure : Time to peak (min)
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
MidiCAT method measure : Thrombin peak (M, Thrombin)
Kinetics of 12 hours following Apixaban treatment in both groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Emilie CHALAYER, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23CH293
  • ANSM (Other Identifier: 2025-A02337-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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