Biomarkers in Multiple Myeloma

Chemotherapy Clinical Trial

— VESICOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259553
• Other study ID #: 2021-0701
• Secondary ID: 2021-A01895-36
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: October 30, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Emilie Chalayer, MD
• Phone: 04 77 91 70 00
• Email: emilie.chalayer[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Multiple Myeloma

Intervention

Other:
• Blood samples
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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of thrombin generation in newly diagnosed and untreated MM	Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy	24 months
Primary	Level of factor VIII in newly diagnosed and untreated MM	Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy	24 months
Primary	Level of D-Dimers in newly diagnosed and untreated MM	Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy	24 months
Primary	Level of pro-coagulant phospholipids in newly diagnosed and untreated MM	Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy	24 months
Secondary	Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset	Correlation between the plasma level of biomarkers and clinical data	24 months
Secondary	Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome	Correlation between the plasma level of biomarkers and clinical data	24 months
Secondary	Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment	Correlation between the plasma level of biomarkers and clinical data	24 months
Secondary	Evaluation of the exposition of Apixaban (Eliquis®)	Plasma level of Apixaban in MM treated patients	24 months