CLARITY QOL STUDY IN RELAPSED REFRACTORY MM
Research type
Research Study
Full title
Clinical decision-making, prognosis, quality of life and satisfaction with care in patients with relapsed/refractory multiple myeloma
IRAS ID
247260
Contact name
Charalampia Kyriakou
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
Ensuring that best therapeutic approach is taken for patients with multiple myeoloma (MM) is extremely important, but also a challenge. Treating of patients with relapsed/refractory multiple myeloma (RRMM) is especially challenging due to diverse presentation of the condition (heterogeneity). Based on our literature review to date most patient reported outcome studies focused on newly diagnosed patients. The aim of the CLARITY study is to collect patient reported outcomes (PROs) in order to understand the value of such outcomes in this patient group and to generate data, which we hope will eventually guide clinicians to better communicate with patients and to better respond to individual patient needs. The study will look at overall survival as predicted by baseline using various rating scales, including patient reported outcomes, but also clinically based prognosis. This will be achieved by collecting data across several centres internationally. Data from current treatment and patient outcomes measures already administered at the centres will be collected for each patient for up to 30 months. The data will be sent and collated at the lead centre at the GIMEMA Foundation in Rome, Italy. The project in the UK will be sponsored by the Chief Investigators employing institution, but the main international sponsor remains the GIMEMA Foundation where the main study analysis will take place. This is a prospective data collection cohort study, which does not introduce any additional treatments or procedures for the patients.
The project will be conducted at 2 centres in the UK, Dr Kyriakou is a consultant haematologist at both centres and will be the Chief Investigator for the study, as well as the principle investigator across both sites. Dr Kyriakou holds a contract with both sites.REC name
London - Central Research Ethics Committee
REC reference
18/LO/1510
Date of REC Opinion
13 Sep 2018
REC opinion
Further Information Favourable Opinion