Biomarkers in Multiple Myeloma

NCT05259553 | Recruiting

• 2 other identifiers: 2021-07012021-A01895-36
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematological Patients; Newly Diagnosed Multiple Myeloma; Chemotherapy

Keywords

hematology; multiple myeloma; chemotherapy; thromboprophylaxis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

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

  24 months

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

  24 months

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

  24 months

• Evaluation of the exposition of Apixaban (Eliquis®)

  24 months

Study Arms (1)

Patients with multiple myeloma

EXPERIMENTAL

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

Other: Blood samples

Interventions

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.

Patients with multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

Hospices Civils de Lyon

Lyon, 69495, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emilie Chalayer, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Chalayer, MD

CONTACT

04 77 91 70 00; emilie.chalayer@chu-st-etienne.fr

Elisabeth Daguenet, PhD

CONTACT

elisabeth.daguenet@icloire.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 28, 2022
• Study Start: May 20, 2022
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)