CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2032-10-03

Brief Summary

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Multiple myeloma patients can be treated with cell therapy, which uses some of their own modified white blood cells (T lymphocytes) to target a protein (BCMA, or B-cell maturation antigen) found on the surface of the myeloma plasma cells. These modified T lymphocytes are called CAR T cells (chimeric antigen receptor T cells). The long-term persistence of these modified lymphocytes, or CAR-BCMA, is a recognized indicator of a good response to treatment. This research aims to study certain markers related to CAR-BCMA cell persistence. This research will be carried out in collaboration with the Laboratory of Ischemia Reperfusion, Metabolism and Sterile Inflammation in Transplantation (IRMETIST) INSERM unit U1313, located at the University of Poitiers. The proposed project will contribute to better patient care in the field of oncology, by identifying immunological cellular markers predictive of an effective response to anti-cancer treatments and/or immunotherapeutic targeting.

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Detailed Description

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Multiple myeloma data will be collected from initial diagnosis and relapses, treatments receive since initial diagnosis and the CAR-T therapy (start of CAR-T therapy, type of CAR-T, responder status). Before and up to 1 year after CART C Cells treatment, blood (7) and bone marrow (3) samples will be sent to a centralised laboratories to analyse immune cells, including CAR-BCMA cells, and measure the expression of certain proteins on their surface (CD95 and CD95L) and the serum-soluble CD95L protein.

Conditions

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Multiple Myeloma (MM)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective interventional study with minimal risks and constraints, descriptive, exploratory, non-randomized, longitudinal, single-center, basic research aim.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Additional Bone Marrow cells and blood sampling

Intervention Type OTHER

Additional Bone Marrow cells and blood sampling

Interventions

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Additional Bone Marrow cells and blood sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient aged 18 and over
* Patient with Multiple Myeloma according to international recommendations,
* Patient about to receive CAR-T cell therapy in accordance with the rules and authorizations in France.

Exclusion Criteria

* Patients with severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study.
* Simultaneous participation in another study with an ongoing exclusion period.
* Individuals receiving enhanced protection, namely minors, pregnant and/or breastfeeding women, individuals deprived of their liberty by a judicial or administrative decision, individuals residing in a healthcare or social care facility, adults under legal guardianship, and finally, patients in emergency situations

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No