Update of the EORTC QLQ-MY20 QOLQ for MM
Research type
Research Study
Full title
Update of the EORTC QLQ-MY20 questionnaire for the assessment of quality of life in Multiple Myeloma patients. Phase I-III Study on behalf of the EORTC Quality of Life Group: Research Protocol
IRAS ID
291375
Contact name
CHARALAMPIA KYRIAKOU
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Duration of Study in the UK
1 years, 0 months, 7 days
Research summary
Multiple Myeloma (MM) is an incurable haematological cancer that affects physical, psychological and social domains of patients’ QoL. Treatment decisions and monitoring of disease within clinical practice are increasingly guided by QoL issues that need to be better defined. The European Organisation for the Research and Treatment of Cancer Myeloma module quality of life questionnaire (EORTC QLQ-MY20)1,2 was published in 1999 and has been widely used alongside the EORTC core quality of life questionnaire (EORTC QLQ-C30) in clinical trials and daily practice. Since the original development of the EORTC QLQ-MY20, treatment for MM has changed dramatically and survival rates have increased. While the original validation of the QLQ-MY20 was largely in newly diagnosed patients the increase in survival means that patients are now undergoing multiple lines of therapy and experiencing multiple relapses.To date there are 42 FDA approved drugs for myeloma (https://www.cancer.gov/about-cancer/treatment/drugs/multiple-myeloma) of which only 15 were available to patients involved in the original QLQ-MY20 validation study. Alongside this, the toxicity profile of the new and forthcoming agents for MM is variable. Due to the vastly improved survival rates and the increase in number of available treatments, the MM patient experience has likely changed since the original development and validation of the QLQ-MY20. Based on this, updates and further validation to the module may be necessary in order to ensure the QLQ-MY20 is relevant to MM patients in the present day and fully captures the disease experience and impacts experienced in MM. While the QLQ-C30 and QLQ-MY20 were acknowledged as the instruments that had undergone the most extensive validation in MM patients, no instruments were identified that covered all issues relevant to patients. Based on this the EORTC wish to update the QLQ-MY20.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0040
Date of REC Opinion
12 Apr 2021
REC opinion
Further Information Favourable Opinion