MedDataX Logo

Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients

NCT ID: NCT06062537

Last Updated: 2025-05-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-19

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.

This is a multicenter, prospective, observational study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT05572515

Relapsed or Refractory Multiple Myeloma
ACTIVE_NOT_RECRUITING PHASE3

Study on the Clinical Efficacy of Teclistamab

NCT06477783

Multiple Myeloma Hematologic Diseases
RECRUITING

A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma

NCT07030517

Multiple Myeloma
RECRUITING PHASE4

Plan Development for Giving Teclistamab in the Outpatient Setting

NCT06251076

Multiple Myeloma Relapsed Cancer Refractory Cancer
RECRUITING PHASE4

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098

Hematological Malignancies
ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)

Exclusion Criteria

* Patients alive at the start of the study who did not receive study information or who objected to the collection of data
* Patients who received teclistamab as part of an interventional clinical trial
* Patients who are initiating teclistamab as part of a current interventional clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

Intergroupe Francophone du Myelome

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens Picardie

Amiens, , France

Site Status

CH d'ANNECY

Annecy, , France

Site Status

Centre hospitalier d'Argenteuil

Argenteuil, , France

Site Status

Hopital de la cote Basque

Bayonne, , France

Site Status

CHU de Besançon

Besançon, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

Centre hospitalier de Brive-la-Gaillarde

Brive-la-Gaillarde, , France

Site Status

CHU CAEN

Caen, , France

Site Status

Centre hospitalier Métropole de Savoie

Chambéry, , France

Site Status

CHU Clermont-Ferrand Site Estaing

Clermont-Ferrand, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

Chu Dijon

Dijon, , France

Site Status

CH Dunkerque

Dunkirk, , France

Site Status

CHU de Lille

Lille, , France

Site Status

Groupe hospitalier Bretagne Sud

Lorient, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

CH de METZ

Metz, , France

Site Status

CHU Saint-Eloi - CHU de Montpellier

Montpellier, , France

Site Status

Chu de Nantes

Nantes, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Hopital Necker

Paris, , France

Site Status

Hopital saint louis

Paris, , France

Site Status

CH Perpignan

Perpignan, , France

Site Status

Hopital Novo

Pontoise, , France

Site Status

Chu de Rennes

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status

Institut de Cancérologie Strasbourg Europe

Strasbourg, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHU de Tours

Tours, , France

Site Status

CH Bretagne Atlantique

Vannes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IFM 2023-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
NCT05338775 ACTIVE_NOT_RECRUITING PHASE1
A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
NCT06425991 ACTIVE_NOT_RECRUITING PHASE1
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
NCT05945524 RECRUITING NA
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
NCT05572229 RECRUITING PHASE2
Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients
NCT05463939 APPROVED_FOR_MARKETING
Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)
NCT06100237 RECRUITING PHASE2
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
NCT03145181 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
NCT05161598 NO_LONGER_AVAILABLE
A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma
NCT07105059 RECRUITING PHASE1
Limited-duration Teclistamab
NCT05932680 RECRUITING PHASE2
A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials
NCT06285318 RECRUITING
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
NCT04586426 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
NCT06208150 RECRUITING PHASE3
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
NCT05243797 RECRUITING PHASE3
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
NCT05849610 ACTIVE_NOT_RECRUITING PHASE2
ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT06588660 TERMINATED PHASE1
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
NCT05972135 RECRUITING PHASE2
A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT01564537 COMPLETED PHASE3
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
NCT05695508 RECRUITING PHASE2
A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients
NCT04688853 UNKNOWN PHASE1
An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients
NCT03606577 ACTIVE_NOT_RECRUITING PHASE2
A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
NCT04722146 ACTIVE_NOT_RECRUITING PHASE1
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
NCT05552222 RECRUITING PHASE3
Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma
NCT06465316 RECRUITING PHASE1
Ixazomib in Combination With Thalidomide - Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
NCT02410694 COMPLETED PHASE2