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

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT06062537
• Lead Sponsor: Intergroupe Francophone du Myelome

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-19
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate (ORR) of teclistamab according to IMWG criteria	24 months	ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

Secondary Outcome Measures

Name	Time	Method
Effectiveness of teclistamab	24 months	Time to discontinuation (TTD)
Adverse events of interest	24 months	ICANS, CSR and infections
Conditions of use	24 months	Patients' profiles (demographics characteristics and medical history); - Injection facilities and schedules during follow up phase

Trial Locations

Locations (20)

Hopital de la cote Basque; 🇫🇷 Bayonne, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU CAEN; 🇫🇷 Caen, France

CHU de Lyon; 🇫🇷 Lyon, France

CH d'ANNECY; 🇫🇷 Annecy, France

Chu Dijon; 🇫🇷 Dijon, France

CH Dunkerque; 🇫🇷 Dunkerque, France

CHU de Lille; 🇫🇷 Lille, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

CH de METZ; 🇫🇷 Metz, France

CHU de Nice; 🇫🇷 Nice, France

CH Perpignan; 🇫🇷 Perpignan, France

Hopital Novo; 🇫🇷 Pontoise, France

Chu de Rennes; 🇫🇷 Rennes, France

Hopital Necker; 🇫🇷 Paris, France

Hopital saint louis; 🇫🇷 Paris, France

CHU de Tours; 🇫🇷 Tours, France

CH Bretagne Atlantique; 🇫🇷 Vannes, France

CHU Toulouse; 🇫🇷 Toulouse, France

Chu de Nantes; 🇫🇷 Nantes, France