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

N/AActive Not RecruitingNCT06062537

Intergroupe Francophone du Myelome200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (31)

CHU Amiens Picardie

Amiens, France

Outcomes

Primary Outcomes

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

ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

Time frame: 6 months

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

ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

Time frame: 24 months

Secondary Outcomes

Effectiveness of teclistamab

Progression Free Survival 1 and 2 (PFS)

Time frame: 24 months

Effectiveness of teclistamab

Overall survival (OS)

Time frame: 24 months

Effectiveness of teclistamab

Duration of overall response (DOR)

Time frame: 24 months

Effectiveness of teclistamab

Response rate (sCR, CR, VGPR, PR)

Time frame: 24 months

Effectiveness of teclistamab

Time to best response

Time frame: 24 months

Effectiveness of teclistamab

Time to next treatment (TTNT)

Time frame: 24 months

Effectiveness of teclistamab

Time to discontinuation (TTD)

Data from ClinicalTrials.gov

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