Biomarkers in Multiple Myeloma

NCT ID: NCT05259553

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2027-10-30

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.

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.

Conditions

Hematological Patients; Newly Diagnosed Multiple Myeloma; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients with multiple myeloma

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

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Chalayer, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

Hospices Civils de Lyon

Lyon, , France

Site Status: RECRUITING

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emilie Chalayer, MD

Role: CONTACT

emilie.chalayer@chu-st-etienne.fr

04 77 91 70 00 ext. +33

Elisabeth Daguenet, PhD

Role: CONTACT

elisabeth.daguenet@icloire.fr

Facility Contacts

Lionel Karlin, MD

Role: primary

Emilie Chalayer, MD

Role: primary

Other Identifiers

2021-A01895-36

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0701

Identifier Type: -

Identifier Source: org_study_id