Feasibility of a progressive, walking-based exercise programme for monoclonal gammopathy of undetermined significance and smouldering multiple myeloma: a single-arm pilot trial.

niversity of Bath0 个研究点目标入组 20 人开始时间: 2018年5月14日最近更新: 2024年2月19日

适应症

试验速览

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38317104/ (added 06/02/2024)

•1. Diagnostic criteria:
•1.1. SMM. Defined by IMWG criteria as absence of MM defining events or amyloidosis, AND either: (i) serum monoclonal protein (IgG or IgA) >30 g/L OR urinary monoclonal protein >500 mg per 24 h, AND/OR (ii) clonal bone marrow plasma cells 10-60%. People with SMM, given their higher risk of progressing to MM, will initially be prioritised for enrollment into the trial, followed by people with MGUS, described next
•1.2. MGUS. Defined by IMWG criteria as absence of end-organ damage attributable to the plasma cell proliferative disorder (such as hypercalcaemia, renal insufficiency, anaemia, and bone lesions [CRAB]), or amyloidosis AND BMPC <10% AND serum M-protein <30 g/L
•2. Age >18 years (adults and seniors)

•1. World Health Organisation (WHO) performance status >1
•2. Pregnancy
•3. Deemed unsafe to exercise according to the Physical Activity Readiness Questionnaire
•4. Any comorbidity that is likely to progress or be exacerbated over the course of the trial period
•5. Cognitive impairment deemed a risk by the healthcare team for participation in the trial
•6. Unable to understand explanations and/or provide informed consent
•7. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial

发起方

niversity of Bath