Informations générales (source: ClinicalTrials.gov)
A Retrospective, Multicountry Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Treated With T-cell Redirectors Outside of Clinical Trials (REALiTEC/TAL)
Observational
Janssen-Cilag Ltd. (Voir sur ClinicalTrials)
décembre 2023
octobre 2026
24 mai 2025
The purpose of this study is to describe the use of teclistamab/talquetamab in the
treatment of patients with RRMM outside of clinical trials.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHRU de Nancy - Hopitaux de Brabois - 54500 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes hotel Dieu - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Albert Calmette - CHU Lille - 59037 - Lille cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75475 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer Toulouse Oncopole - 31100 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Have a documented diagnosis of multiple myeloma
- Received the first dose of teclistamab on or before 31 December 2022, regardless of
the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose
of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of
the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose
of talquetamab on or before 31 December 2023, regardless of the duration of
talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab
& talquetamab can be included in both REALiTEC and REALiTAL cohorts
- Received at least one dose of teclistamab/talquetamab
- Provision of a patient-signed informed consent form (ICF), or an ICF waiver for
deceased patients as applicable based on country/site-specific requirements
- Have a documented diagnosis of multiple myeloma
- Received the first dose of teclistamab on or before 31 December 2022, regardless of
the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose
of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of
the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose
of talquetamab on or before 31 December 2023, regardless of the duration of
talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab
& talquetamab can be included in both REALiTEC and REALiTAL cohorts
- Received at least one dose of teclistamab/talquetamab
- Provision of a patient-signed informed consent form (ICF), or an ICF waiver for
deceased patients as applicable based on country/site-specific requirements
- To be excluded from REALiTEC cohorts if received teclistamab as part of an
interventional clinical trial
- To be excluded from REALiTAL cohort if received talquetamab as part of an
interventional clinical trial
- Participants who have received teclistamab as part of a Janssen pre-approval access
program are excluded from the REALiTEC Cohort 2