REALiTEC

• Research type

  Research Study

• Full title

  A Retrospective, Multicountry Study of Clinical Outcomes in Patients with Relapsed/Refractory Multiple Myeloma Treated with T-cell Redirectors Outside of Clinical Trials

• IRAS ID

  333427

• Contact name

  Bhuvan Kishore

• Contact email

  bhuvan.kishore@nhs.net

• Sponsor organisation

  Janssen

• Duration of Study in the UK

  0 years, 9 months, 1 days

• Research summary

  The purpose of this study is to describe the use of the drug teclistamab in the treatment of relapsed/refractory Multiple Myeloma in standard clinical practice. Multiple Myeloma is a cancer of the plasma cells in the bone marrow. There are multiple treatments for Multiple Myeloma, but the disease relapses in the majority of patients, and with each successive relapse, symptoms return and quality of life worsens. Teclistimab has shown promising results in patients with relapsed/refractory myeloma, but further data is required to measure the safety and effectiveness of the treatment in routine clincal practice.

  This study is a retrospective, non-interventional study to describe the use of teclistimab in standard clinical practice. Only data available from patient medical notes will be collected for the study. Data will be collected from both living and deceased patients. The data collected from the patient notes will include:
  - Patient and disease history
  - History of previous treatments for the condition
  - Information about treatment with teclistimab, including treatment patterns, effectiveness and any safety issues identified
  - Medical resource use during treatment with teclistimab
  - Survival data
  - Information about subsequent treatments

  Data will be collected from approximately 200 patients across multiple hospital sites.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  23/SC/0424

• Date of REC Opinion

  24 Jan 2024

• REC opinion

  Further Information Favourable Opinion