Multiple Myeloma (update of MY20)

Since the original development of the European Organisation for the Research and Treatment of Cancer Myeloma Module Quality of Life Questionnaire (EORTC QLQ-MY20), treatment for Multiple myeloma (MM) has changed dramatically and survival rates have increased. Due to this the MM patient experience has likely changed since the original development and validation of the QLQ-MY20. Updates and further validation to the module are being made to ensure the QLQ-MY20 is relevant to MM patients and fully captures the disease experience and impacts experienced in MM.

Publication of Phase 1a literature review in the Blood Cancer Journal in May 2023
Phase I-II Report to PMDC – reviewed- response to the comments – awaiting final response
Submit the Fast track Phase III application – ready for submission when the Report from Phase I-II is approved by the PMDC (Note for the subsequent study phases Dr Sally Wheelwright will be the CO CI and not Adelphi)

Submit paper with Phase I-II findings after the final approval from PMDC to the committee for review and then to a Haematology Journal

Current status:

Phase I-II completed.

Prepared the Fast track Phase III application after having the final feedback for the Report from Phase I-II

Following Phase II, we will pre-test the updated module MY24 with MM patients to identify and rectify any potential problems and to identify missing or redundant issues in Phase IIIa.

Application for the Phase III in November and when approved to proceed to recruitment Q1 2026.

NOTE:

The International Myeloma Working Group (IMWG) that the PI is a core member, is aware of the development of this module and more sites have expressed interest in participating to the Phase III of the module.

There is a lot of interest from Pharma about the timelines of the module development that would be keen in participating in the validation process as well

The IMWG has developed a subgroup focusing on QOL that the PI is one of the core members and we will soon publish consensus guidelines on PROMS/QOL in MM. International MM experts, FDA and EMA representatives and the Myeloma Patient European Organisation are involved in this project as well.

This project aims to update the EORTC QLQ-MY20 questionnaire used for the assessment of quality of life in Multiple Myeloma patients to ensure it is relevant to the current treatment and disease outcome developments.