About this trial
The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 teclistamab from 01 January 2025 to 31 December 2025, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 3) 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
Disqualifiers
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 and REALiTEC Cohort 3
Trial population
Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Teclistamab
Other interventionNo Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Talquetamab
Other interventionNo Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Treatment groups
Trial outcomes
Primary outcomes
Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials
Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.
Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria.
Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria.
Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria.
Secondary outcomes
Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
Treatment patterns including healthcare setting and treatment schedules will be reported.
Sponsors and contacts
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