VESICOM: Biomarkers in Multiple Myeloma

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05259553

Collaborator

(none)

Enrollment

Locations

Arm

52.9

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Patients Newly Diagnosed Multiple Myeloma Chemotherapy	Other: Blood samples	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Anticipated Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Dec 15, 2025

Anticipated Study Completion Date :

Jul 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with multiple myeloma Adult patient, over 18 years old, with newly diagnosed multiple myeloma, indication of chemotherapy.	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.

Arm

Intervention/Treatment

Experimental: Patients with multiple myeloma

Adult patient, over 18 years old, with newly diagnosed multiple myeloma, indication of chemotherapy.

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.

Outcome Measures

Primary Outcome Measures

Level of thrombin generation in newly diagnosed and untreated MM [24 months]
Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of factor VIII in newly diagnosed and untreated MM [24 months]
Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of D-Dimers in newly diagnosed and untreated MM [24 months]
Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of pro-coagulant phospholipids in newly diagnosed and untreated MM [24 months]
Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy

Secondary Outcome Measures

Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset [24 months]
Correlation between the plasma level of biomarkers and clinical data
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome [24 months]
Correlation between the plasma level of biomarkers and clinical data
Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment [24 months]
Correlation between the plasma level of biomarkers and clinical data
Evaluation of the exposition of Apixaban (Eliquis®) [24 months]
Plasma level of Apixaban in MM treated patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.