Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05259553

Biomarkers in Multiple Myeloma

The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

Recruiting

Interested in participating?

Request Info

Key information

About this study

There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient affiliated to a social security regimen or beneficiary of the same
  • Signed written informed consent form
  • Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.

Exclusion criteria

  • Pregnant women
  • Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
  • Refusing participation
  • Patient whose follow-up or life expectancy is less than 6 months.

Treatment and study plan

Blood Samples

Other

Peripheral blood sampling will be performed at different time points of the study, for a total volume of 20-40 mL:

  • Sampling before MM treatment,
  • Sampling during MM treatment (at 3 months post-initiation if no autograft or before autograft),
  • Only for Patients treated with Apixaban or Eliquis®, 2 additional samplings during MM treatment for pharmacokinetics analysis.

Primary outcomes

  1. Level of thrombin generation in newly diagnosed and untreated MM

    Time frame: 24 months

    Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy

  2. Level of factor VIII in newly diagnosed and untreated MM

    Time frame: 24 months

    Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy

  3. Level of D-Dimers in newly diagnosed and untreated MM

    Time frame: 24 months

    Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy

  4. Level of pro-coagulant phospholipids in newly diagnosed and untreated MM

    Time frame: 24 months

    Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy

Secondary outcomes

  1. Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset

    Time frame: 24 months

    Correlation between the plasma level of biomarkers and clinical data

  2. Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome

    Time frame: 24 months

    Correlation between the plasma level of biomarkers and clinical data

  3. Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment

    Time frame: 24 months

    Correlation between the plasma level of biomarkers and clinical data

  4. Evaluation of the exposition of Apixaban (Eliquis®)

    Time frame: 24 months

    Plasma level of Apixaban in MM treated patients

Study contacts

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

Elisabeth Daguenet, PhD

CONTACT

[email protected]

Emilie Chalayer, MD

CONTACT

[email protected]

04 77 91 70 00 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)

Acronym: VESICOM

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Feb 28, 2022
Registry last updated
Apr 9, 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.

Published trials that share one or more normalized conditions with this study.