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

Study Overview
=================
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.

Official Title
-----------------
Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of teclistamab | Progression Free Survival 1 and 2 (PFS) | 24 months | 
| Effectiveness of teclistamab | Overall survival (OS) | 24 months | 
| Effectiveness of teclistamab | Duration of overall response (DOR) | 24 months | 
| Effectiveness of teclistamab | Response rate (sCR, CR, VGPR, PR) | 24 months | 
| Effectiveness of teclistamab | Time to best response | 24 months | 
| Effectiveness of teclistamab | Time to next treatment (TTNT) | 24 months | 
| Effectiveness of teclistamab | Time to discontinuation (TTD) | 24 months | 
| Adverse events of interest | ICANS, CSR and infections | 24 months | 
| Conditions of use | Patients' profiles (demographics characteristics and medical history) - Injection facilities and schedules during step-up dosing phase | 1 month | 
| Conditions of use | Patients' profiles (demographics characteristics and medical history) - Injection facilities and schedules during follow up phase | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
teclistamab, refractory multiple myeloma, real word evidence study