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Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination (ResisTec)

Primary Purpose

Multiple Myeloma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone marrow sampling
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma focused on measuring Teclistamab, Resistance, Immune Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: With multiple myeloma Who receive Teclistamab Consent form signed Exclusion Criteria: Patient under legal protection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Analysis of bone marrow

    Arm Description

    Analysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles

    Outcomes

    Primary Outcome Measures

    Response to teclistamab at 12 weeks
    response according to International Myeloma Working Group criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2023
    Last Updated
    July 11, 2023
    Sponsor
    University Hospital, Toulouse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05945524
    Brief Title
    Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
    Acronym
    ResisTec
    Official Title
    Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2026 (Anticipated)
    Study Completion Date
    May 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to discover the immune and oncogenomic features that distinguish patients who respond to teclistamab from patients who are primarily resistant. Moreover, phenotypic and genotypic characteristics that occur with secondary resistance to teclistamab will be analyzed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Teclistamab, Resistance, Immune Cell

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Analysis of bone marrow
    Arm Type
    Experimental
    Arm Description
    Analysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles
    Intervention Type
    Other
    Intervention Name(s)
    Bone marrow sampling
    Intervention Description
    Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)
    Primary Outcome Measure Information:
    Title
    Response to teclistamab at 12 weeks
    Description
    response according to International Myeloma Working Group criteria
    Time Frame
    at day 1 Cycle 4 (each cycle is 28 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: With multiple myeloma Who receive Teclistamab Consent form signed Exclusion Criteria: Patient under legal protection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hervé AVET LOISEAU, MD, PhD
    Phone
    +33 531 156 142
    Ext
    33
    Email
    avetloiseau.herve@iuct-oncopole.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hervé AVET LOISEAU, MD, PhD
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination

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