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

Condition(s) studied

Investigational drug(s) / intervention(s)

Teclistamab: No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

Talquetamab: No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (68)

+ 28 more sites — see the full list on the official registry below.

More Janssen-Cilag Ltd. trials in the UK