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NCT05945524 Clinical Trial

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

Multiple Myeloma Clinical Trial

— ResisTec  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05945524
Other study ID # RC31/23/0278
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date May 31, 2026

Study information
Verified date July 2023
Source University Hospital, Toulouse
Contact Hervé AVET LOISEAU, MD, PhD
Phone +33 531 156 142
Email avetloiseau.herve@iuct-oncopole.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date May 31, 2026
Est. primary completion date May 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - With multiple myeloma - Who receive Teclistamab - Consent form signed Exclusion Criteria: - Patient under legal protection

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Bone marrow sampling
Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Outcome
Type Measure Description Time frame Safety issue
Primary Response to teclistamab at 12 weeks response according to International Myeloma Working Group criteria at day 1 Cycle 4 (each cycle is 28 days)
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