About this trial
MM-Exercise is a prospective, single-centre, observational pilot study of patients with newly diagnosed multiple myeloma who have not yet started chemotherapy and whose resting echocardiogram is unremarkable or only mildly abnormal (preserved left ventricular ejection fraction \[LVEF\] ≥50%, at most grade I diastolic dysfunction). The study tests whether a relevant proportion of these patients already exhibit a central (cardiac) limitation of exercise capacity - defined as a cardiac output to oxygen uptake slope (CO/VO2 slope) below 5 - despite the absence of overt cardiac disease on resting assessment, and whether this exercise-derived marker correlates with subclinical myocardial tissue abnormalities on cardiac magnetic resonance imaging (CMR) and with heart-failure hospitalisation and mortality over 12 months. Eighty patients referred in comparable numbers from the haemato-oncology departments will undergo a single comprehensive baseline assessment (medical and sports history, cardiac biomarkers, resting echocardiography, 6-minute walk distance, combined cardiopulmonary exercise testing with stress echocardiography \[CPETecho\], and CMR with T1-/T2-mapping and late gadolinium enhancement) prior to chemotherapy initiation, followed by in-person clinical follow-up visits 3 and 12 months after each patient's own baseline visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed newly diagnosed multiple myeloma and chemotherapy not yet initiated
Resting echocardiogram with preserved left ventricular ejection fraction (≥50%) and at most mild (grade I) diastolic dysfunction with no echocardiographic signs of clinically manifest cardiac involvement
Age 18-99 years
Written informed consent
Disqualifiers
New York Heart Failure Association Class IV heart failure, or recent decompensated heart failure requiring inpatient recompensation
Suspected new or progressive coronary artery disease
Estimated glomerular filtration rate <30 mL/min/1.73m², or contraindication to gadolinium-based contrast agents
Severe anaemia, defined as haemoglobin <8 g/dL at baseline
Trial population
Adult patients with newly diagnosed multiple myeloma who have not yet initiated chemotherapy, recruited via the haemato-oncology outpatient clinics.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Point prevalence of a reduced cardiac output to oxygen uptake slope at baseline.
Point prevalence of a reduced cardiac output to oxygen uptake slope (CO/VO2 slope \<5) at baseline, as a marker of central (cardiac) limitation of exercise capacity.
Secondary outcomes
Cardiac output reserve during exercise
Difference between cardiac output at rest and peak exercise
Heart rate reserve during exercise
Difference of heart rate between rest and peak exercise
Stroke volume reserve during exercise
Difference of stroke volume between peak exercise and rest
Minute ventilation to carbon dioxide production slope
Slope between minute ventilation and carbon dioxide production
Other outcomes
Association of baseline cardiac output to oxygen uptake with heart-failure hospitalisation, cardiovascular and all-cause mortality.
Association of baseline cardiac output to oxygen uptake with heart-failure hospitalisation, cardiovascular and all-cause mortality.
Change from baseline in cardiac biomarkers
Change of serum concentration in cardiac biomarkers (high-sensitivity troponin, NT-proBNP) from baseline (V1)
Change in quality of life
Change from baseline (V1) in quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, 0 being the worst health condition and 100 being the best condition
Sponsors and contacts
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