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
About this trial
This is an interventional other trial for Multiple Myeloma focused on measuring Teclistamab, Resistance, Immune Cell
Eligibility Criteria
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
NCT ID
NCT05945524
First Posted
May 16, 2023
Last Updated
July 11, 2023
Sponsor
University Hospital, Toulouse
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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