Active — Not RecruitingNot Applicable

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

France200 participantsStarted 2023-09-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

overall response rate (ORR) of teclistamab according to IMWG criteria

Timeframe: 6 months

overall response rate (ORR) of teclistamab according to IMWG criteria

Timeframe: 24 months

Trial details

NCT IDNCT06062537

SponsorIntergroupe Francophone du Myelome

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Multiple Myeloma trials