MUK Nine a: Screening Study
Research type
Research Study
Full title
MUKnine a: An observational and screening study to identify high risk myeloma patients suitable for novel treatment approaches and determine treatment outcomes for non-high risk myeloma patients
IRAS ID
214135
Contact name
Clare Skinner
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 31 days
Research summary
Multiple myeloma is a disorder of plasma cells in the bone marrow. It is the second most common haematologic cancer in the EU, causing about 21,000 deaths in the EU in 2008.
Approximately 20% of patients with myeloma have an extremely poor prognosis with a survival of less than 3 years and these patients are characterised as having high risk (HR) disease. There have been no significant improvements in outcome over the last decade for patients with HR disease. However recent data has demonstrated the efficacy of the combination of multiple novel agents in high risk disease.
The aim of this phase II study is to assess whether future trials in this setting are feasible, and to determine risk status for participants with myeloma, in order to recruit high risk participants into MUK nine B. Participants who are found not to be high risk will be treated with standard treatment. Patients will be followed up and data and biological samples will be centrally collected according to the schedule of MUK nine A to generate a knowledge resource about real-world treatment outcomes in newly diagnosed myeloma in the UK.
The study includes approx 560 adult participants undergoing bone marrow investigation due to suspected symptomatic multiple myeloma or participants with biopsy confirmed symptomatic multiple myeloma, willing to undergo a further study bone marrow aspirate for molecular profiling. Participants will be recruited from approximately 30 approved NHS Hospitals throughout the UK.
An imaging aspect to the trial has been added to explore the association of MRI imaging with Minimal Residual Disease (MRD) by combing the MRI scan information with the laboratory MRD assessments. This will be used look at survival. Joint MRI scan and MRD assessments will be performed at 3 time points in the trial.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/0022
Date of REC Opinion
26 Jan 2017
REC opinion
Favourable Opinion