Retrospective cohort of multiple myeloma patients
Research type
Research Study
Full title
Retrospective cohort of relapsing/refractory multiple myeloma(RRMM)patients, treated in terms of clinical practice, who have received at least three prior lines of antimyeloma therapy to be compared with patients enrolled in GSK's clinical trial NCT03525678 of GSK2857916 medicine (BCMA).
IRAS ID
267025
Contact name
Rakesh Popat
Contact email
Sponsor organisation
Glaxo SmithKline
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
This is a multi-country, multi-site, retrospective observational chart review study conducted in France, Germany, Italy, Spain and UK. A retrospective cohort observational study of a real-world treatment practice. The study focuses on patients who had relapsing/refractory multiple myeloma (RRMM) and have been treated in clinical practices. Participating physicians select patients according to the inclusion and exclusion criteria and revision of clinical charts for data extraction. Patient data will be obtained from the patients medical records and entered into the electronic case report form (eCRF) in an anonymised way.
Participant physicians will be asked to retrospectively examine the patients’ medical records for patient eligibility for a 24-month data collection period. Patients will be identified in a backward consecutive way from 30th June 2018 to 30th June 2016 to standardise the selection process between sites and minimise the selection bias within the sites.
The data collection period will cover the time from index date to date of data collection (latest 31st August 2019), death or loss of follow-up, whichever occurs first. Patient who are alive and are still in the study (no loss of follow-up) at date of data collection will have a minimum follow-up period of 14 months. Changes in treatment will not be considered a reason for end of data collection.
The index date will be defined as the date of initiation of fourth or later lines of therapy (if patients receive an active treatment), or date of progression after 3rd line therapy (if patients receive best supportive care). In the case that the patient initiated several lines of therapy during the historical cohort window period the most recent line of therapy will be considered as index date.REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1127
Date of REC Opinion
28 Jun 2019
REC opinion
Favourable Opinion