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NCT Number: NCT06474182

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Total Knee Replacement Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Charlotte DOUBLET, MD

SUB_INVESTIGATOR

Emilie CHALAYER, MD

CONTACT

[email protected]

(0)4 77 82 28 14 ext. 33

Emmanuelle TAVERNIER, MD

SUB_INVESTIGATOR

Hugo THEVENET, MD

SUB_INVESTIGATOR

Jean-Yves BIEN, MD

SUB_INVESTIGATOR

Julien LANOISELEE, MD

SUB_INVESTIGATOR

Jérôme CORNILLON, MD

SUB_INVESTIGATOR

Ludovic FOUILLET, MD

SUB_INVESTIGATOR

Manon SAPET, MD

SUB_INVESTIGATOR

Tiphany NEEL, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sampling

Procedure

Blood sampling

Apixaban

Drug

Treatment by Apixaban

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. Pharmacodynamics' kinetics of Lagtime

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

    MidiCAT method measure : Lagtime (min)

  4. 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)

  5. Pharmacodynamics' kinetics of Thrombin peak

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

    MidiCAT method measure : Thrombin peak (M, Thrombin)

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie CHALAYER, MD

CONTACT

[email protected]

(0)477822814 ext. 33

Florence RANCON

CONTACT

[email protected]

(0)4 77 82 94 58 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: ProApix

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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