Biomarkers in Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05259553
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emilie Chalayer, MD
Principal Investigator Affiliation CHU de Saint-Etienne
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hematological Patients, Newly Diagnosed Multiple Myeloma, Chemotherapy
Additional Details

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.

Arms & Interventions

Arms

Experimental: Patients with multiple myeloma

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospices Civils de Lyon, Lyon, France

Status

Recruiting

Address

Hospices Civils de Lyon

Lyon, , 69495

Site Contact

Lionel Karlin, MD

emilie.chalayer@chu-st-etienne.fr

04 77 91 70 00

CHU de Saint-Etienne, Saint-Étienne, France

Status

Recruiting

Address

CHU de Saint-Etienne

Saint-Étienne, , 42055

Site Contact

Emilie Chalayer, MD

emilie.chalayer@chu-st-etienne.fr

04 77 91 70 00