A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials (REALiTEC/TAL)

Janssen (J&J Innovative Medicine)

Status: Enrolling

Conditions: Relapsed/Refractory Multiple Myeloma (RRMM)

Treatments: Other: Talquetamab; Other: Teclistamab

Study type: Observational

Funder types: Industry

Identifiers

NCT06285318

64007957MMY4004

Details and patient eligibility

About

The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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

Trial design

600 participants in 3 patient groups

Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 1

Description:

Participants with RRMM who received at least one dose of teclistamab outside of clinical trials on or before 31 December 2022 will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.

Treatment:

Other: Teclistamab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 2

Description:

Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2023 to 31 December 2024, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab.

Treatment:

Other: Teclistamab

Participants with RRMM: Talquetamab Cohort

Description:

Participants with RRMM who received at least one dose of talquetamab outside of clinical trials on or before 31 December 2023 will be enrolled in the study. The data available from the medical records of each enrolled participant will be collected to describe the use of talquetamab.

Treatment:

Other: Talquetamab