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

April 7, 2025 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
        • Contact:
      • Dijon, France, 21000
        • Recruiting
        • Polyclinique du Parc Drevon
        • Contact:
      • Epagny Metz- Tessy, France, 74370
      • Lille, France, 59037
      • Lyon, France, 69373
      • Montpellier, France, 34295
      • Paris, France, 75010
      • Paris, France, 75015
        • Recruiting
        • Hopital Necker
        • Contact:
      • Paris, France, 75012
        • Recruiting
        • Hôpital Saint-Antoine
        • Contact:
      • Pessac, France, 33600
      • Pierre-benite, France, 69495
      • Poitiers, France, 86021
      • Rennes, France, 35033
      • St Priest-en-jarez, France, 42271
      • Toulouse, France, 31059
      • Tours, France, 37044
      • Vandoeuvre Les Nancy, France, 54500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • With multiple myeloma
  • Who receive Teclistamab
  • Consent form signed

Exclusion Criteria:

  • Patient under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Hervé AVET LOISEAU, MD, PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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