Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
ResisTec
1 other identifier
interventional
100
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Sep 2023
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedApril 10, 2025
April 1, 2025
2.5 years
May 16, 2023
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to teclistamab at 12 weeks
response according to International Myeloma Working Group criteria
at day 1 Cycle 4 (each cycle is 28 days)
Study Arms (1)
Analysis of bone marrow
EXPERIMENTALAnalysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles
Interventions
Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)
Eligibility Criteria
You may qualify if:
- With multiple myeloma
- Who receive Teclistamab
- Consent form signed
You may not qualify if:
- Patient under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CHU d'Amiens
Amiens, France, 80054, France
CHU de Caen
Caen, France, 14033, France
Polyclinique du Parc Drevon
Dijon, France, 21000, France
CH Annecy Genevois
Epagny Metz- Tessy, France, 74370, France
CHU de Lille
Lille, France, 59037, France
Centre Léon Bérard
Lyon, France, 69373, France
CHU de Montpellier
Montpellier, France, 34295, France
Hôpital Saint-Louis
Paris, France, 75010, France
Hôpital Saint-Antoine
Paris, France, 75012, France
Hôpital Necker
Paris, France, 75015, France
CHU de Bordeaux
Pessac, France, 33600, France
CHU de Lyon
Pierre-Bénite, France, 69495, France
CHU de Poitiers
Poitiers, France, 86021, France
CHU de Rennes
Rennes, France, 35033, France
CH Saint-Etienne
Saint-Priest-en-Jarez, France, 42271, France
CHU de Toulouse
Toulouse, France, 31059, France
CHU de Tours
Tours, France, 37044, France
CHRU Nancy
Vandœuvre-lès-Nancy, France, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hervé AVET LOISEAU, MD, PhD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2023
First Posted
July 14, 2023
Study Start
September 28, 2023
Primary Completion
March 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share