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RecruitingNCT06474182ProApixUpdated Sep 21, 2026

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

An interventional study of Blood sampling and Apixaban in Multiple Myeloma and Total Knee Replacement, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Multiple Myeloma
  • Total Knee Replacement

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Keywords

  • Multiple myeloma
  • thromboprophylaxis
  • pharmacodynamics
  • coagulability
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 36 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years old,
  • Signed ,
  • 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

Exclusion Criteria:

  • Curative doses of anticoagulation treatment,
  • to Apixaban,
  • Pregnant or breastfeeding woman,
  • Refusal to sign consent,
  • Patient under legal protection.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Blood sampling of patients with de novo multiple myeloma

    Description: Blood sampling of patients with de novo multiple myeloma

    Procedure: Blood sampling · Drug: Apixaban

  • Experimental
    Blood sampling of patients undergoing total knee replacement

    Description: Blood sampling of patients undergoing total knee replacement

    Procedure: Blood sampling · Drug: Apixaban

Interventions

  • ProcedureBlood sampling

    Blood sampling

  • Treatment by Apixaban

06

What researchers measure

Primary outcomes

  1. Endogenous Thrombin potential (nM.min)

    Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment

    Time frame: 2 hours after Apixaban Treatment

Secondary outcomes

  1. Apixaban concentration (ng/mL)

    Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups

    Time frame: Kinetics of 12 hours following Apixaban treatment in both groups

  2. Pharmacodynamics' kinetics of Endogenous Thrombin Potential

    MidiCAT method measure : Endogenous Thrombin Potential (nM.min)

    Time frame: Kinetics of 12 hours following Apixaban treatment in both groups

  3. Pharmacodynamics' kinetics of Lagtime

    MidiCAT method measure : Lagtime (min)

    Time frame: Kinetics of 12 hours following Apixaban treatment in both groups

  4. Pharmacodynamics' kinetics of Time to peak

    MidiCAT method measure : Time to peak (min)

    Time frame: Kinetics of 12 hours following Apixaban treatment in both groups

  5. Pharmacodynamics' kinetics of Thrombin peak

    MidiCAT method measure : Thrombin peak (M, Thrombin)

    Time frame: Kinetics of 12 hours following Apixaban treatment in both groups

07

Study locations

1 of 1 sites recruiting
  • CHU de Saint-Etienne
    Saint-Etienne, 42055, France
    Recruiting
    • Emilie CHALAYER, MD · Contactemilie.chalayer@chu-st-etienne.fr · (0)4 77 82 28 14
    • Jean-Yves BIEN, MD · Sub investigator
    • Jérôme CORNILLON, MD · Sub investigator
    • Charlotte DOUBLET, MD · Sub investigator
    • Ludovic FOUILLET, MD · Sub investigator
    • Julien LANOISELEE, MD · Sub investigator
    • Tiphany NEEL, MD · Sub investigator
    • Manon SAPET, MD · Sub investigator
    • Emmanuelle TAVERNIER, MD · Sub investigator
    • Hugo THEVENET, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 24 months after the start.

Of 172 non-industry interventional studies with no phase under Multiple Myeloma, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 81. This study's planned 24 months is below that.

Counting every sponsor, half of 186 studies reached it within 38 months; a quarter within 20 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2024
First posted
Jun 25, 2024
StartActual
Sep 15, 2025
Primary completionEst.
Sep 2027
CompletionEst.
Mar 2028
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06474182
Responsible party
Sponsor
First posted
Jun 25, 2024
Start date
Sep 15, 2025
Primary completion
Sep 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Emilie CHALAYER, MD
Contact
emilie.chalayer@chu-st-etienne.fr
(0)477822814 ext. 33
Florence RANCON
Contact
florence.rancon@chu-st-etienne.fr
(0)4 77 82 94 58 ext. 33
Emilie CHALAYER, MD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Apixaban

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