ResisTec: Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05945524
Collaborator
(none)
100
1
33
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
Anticipated Study Start Date
:
Sep 1, 2023
Anticipated Primary Completion Date
:
May 31, 2026
Anticipated Study Completion Date
:
May 31, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Analysis of bone marrow Analysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles |
Other: Bone marrow sampling
Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)
|
Outcome Measures
Primary Outcome Measures
- Response to teclistamab at 12 weeks [at day 1 Cycle 4 (each cycle is 28 days)]
response according to International Myeloma Working Group criteria
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
With multiple myeloma
-
Who receive Teclistamab
-
Consent form signed
Exclusion Criteria:
- Patient under legal protection
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Hervé AVET LOISEAU, MD, PhD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05945524
Other Study ID Numbers:
- RC31/23/0278
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms: