Relapsed/Refractory Multiple Myeloma (RRMM)
Conditions
Brief summary
The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
Interventions
OTHERTeclistamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
OTHERTalquetamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
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 and REALiTEC Cohort 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials | Baseline (Day 1) | 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 | Up to 40 months | 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 | Up to 40 months | 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 | Up to 40 months | 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. |
| Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Up to 40 months | DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria. |
| Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Up to 40 months | Number of participants with MRD negative rate will be assessed. |
| Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months) | OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death. |
| Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Up to 40 months | PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first. |
| Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Up to 40 months | TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment. |
| Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials | Baseline (Day 1) up to end of treatment (up to 40 months) | Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials | Baseline (Day 1) up to end of treatment (up to 40 months) | Treatment patterns including healthcare setting and treatment schedules will be reported. |
Countries
Denmark, France, Germany, Greece, Ireland, Israel, Italy, Norway, Spain, Sweden, United Kingdom
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen-Cilag Limited Clinical Trial
Janssen-Cilag Limited
Outcome results
None listed