Multiple Myeloma (update of MY20)

This is a Phase 1 to Phase 3 study to update the QLQ-MY20 module.

The European Organisation for the Research and Treatment of Cancer (EORTC) developed the Multiple Myeloma (MM) module quality of life (QoL) questionnaire (QLQ-MY20) in 1999 and it has been widely used alongside the EORTC core quality of life questionnaire (EORTC QLQ-C30) in clinical trials and daily practice. Due to dramatic improvements and developments in the treatment of MM since the QLQ-MY20 was first developed, it is likely that the MM patient experience has changed. Updates and further validation to the module are therefore necessary to ensure the QLQ-MY20 is relevant and fully captures the disease experience and impacts experienced in MM.

The overall aim of this study is to update the EORTC QLQ-MY20 questionnaire for the assessment of QoL in MM patients to ensure it is relevant to the current treatment and disease outcome developments. To achieve this aim a combination of literature reviews and qualitative interviews with both MM patients and health care professionals are being performed.

To date, two literature reviews have been performed, one to identify studies that have used the EORTC QLQ-MY20 and summarise potential methodological problems with the module, and one to identify studies that report on the potential QoL issues associated with new treatments. These literature reviews will feed into the next stage of the research in which qualitative interviews will be conducted with MM patients (n=90) and Health care professionals (n=20) to discuss potential changes to the issues covered in the EORTC QLQ-MY20. Once completed new concepts/issues identified through both the literature review and interviews will be converted into items and a new provisional MY20 module will be developed. Finally, this new provisional version of the questionnaire will be tested and discussed with patients (n=90) to identify and solve any potential problems in administration and to identify missing or redundant issues.

•Abstract was presented at the International Myeloma Group Workshop with good feedback during the meeting

•Two literature reviews have been performed to gather information on the current use of the questionnaire. One paper has been published at Blood Cancer Journal and the second paper will be also submitted soon for review

•Collaborating sites have now Ethics Approval and have started recruitment

Current status:

This study has completed the literature reviews and centres are now open for the interviews with patients and health care professionals to complete Phase I&II. UK, Croatian, Greek, Austrian sites are recruiting. Soon to open after getting ethical approval Israel, Netherlands and Spanish sites

The EORTC QLQ-MY20 is a questionnaire that is designed to measure the quality of life of people with multiple myeloma. This questionnaire was originally developed in 1999. Since then new cancer treatments have been developed and this work aims to update the questionnaire to ensure that the questions adequately capture patients experience.