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

NCT ID: NCT05945524

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Analysis of bone marrow

Analysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles

Group Type EXPERIMENTAL

Bone marrow sampling

Intervention Type OTHER

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

Interventions

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Bone marrow sampling

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient under legal protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé AVET LOISEAU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU d'Amiens

Amiens, France, France

Site Status RECRUITING

CHU de Caen

Caen, France, France

Site Status RECRUITING

Polyclinique du Parc Drevon

Dijon, France, France

Site Status RECRUITING

CH Annecy Genevois

Epagny Metz- Tessy, France, France

Site Status RECRUITING

CHU de Lille

Lille, France, France

Site Status RECRUITING

Centre Léon Bérard

Lyon, France, France

Site Status RECRUITING

CHU de Montpellier

Montpellier, France, France

Site Status RECRUITING

Hôpital Saint-Louis

Paris, France, France

Site Status RECRUITING

Hôpital Saint-Antoine

Paris, France, France

Site Status RECRUITING

Hôpital Necker

Paris, France, France

Site Status RECRUITING

CHU de Bordeaux

Pessac, France, France

Site Status RECRUITING

CHU de Lyon

Pierre-Bénite, France, France

Site Status RECRUITING

CHU de Poitiers

Poitiers, France, France

Site Status RECRUITING

CHU de Rennes

Rennes, France, France

Site Status RECRUITING

CH Saint-Etienne

Saint-Priest-en-Jarez, France, France

Site Status RECRUITING

CHU de Toulouse

Toulouse, France, France

Site Status RECRUITING

CHU de Tours

Tours, France, France

Site Status RECRUITING

CHRU Nancy

Vandœuvre-lès-Nancy, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hervé AVET LOISEAU, MD, PhD

Role: CONTACT

+33 531 156 142 ext. 33

Facility Contacts

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Lydia MONTES, MD

Role: primary

0222455482 ext. 33

Margaret MACRO, MD, PhD

Role: primary

0231272633 ext. 33

Ingrid LAFON, MD

Role: primary

0380294506 ext. 33

Frédérique ORSINI PIOCELLE, MD

Role: primary

0450636144 ext. 33

Salomon MANIER, MD

Role: primary

0320444292 ext. 33

Philippe REY, MD

Role: primary

0478782737 ext. 33

Laure VINCENT, MD

Role: primary

0467338362 ext. 33

Bertrand ARNULF, MD, PhD

Role: primary

0142499695 ext. 33

Mohamad MOTHY, MD

Role: primary

0149282620 ext. 33

Laurent FRENZEL, MD

Role: primary

0144495292 ext. 33

Cyrille HULIN, MD

Role: primary

0557623372 ext. 33

Lionel KARLIN, MD

Role: primary

0448864309 ext. 33

Xavier LELEU, MD, PhD

Role: primary

0549444201 ext. 33

Olivier DECAUX, MD, PhD

Role: primary

0299287692 ext. 33

Emilie CHALAYER, MD

Role: primary

0477917061 ext. 33

Aurore PERROT, MD, PhD

Role: primary

0531156490 ext. 33

Thomas CHALOPIN, MD

Role: primary

0247473712 ext. 33

Caroline JACQUET, MD

Role: primary

0383155249 ext. 33

Other Identifiers

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RC31/23/0278

Identifier Type: -

Identifier Source: org_study_id

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