Exercise Phenotyping Prior to Chemotherapy in Newly Diagnosed Multiple Myeloma (MM-Exercise)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorTechnical University of Munich

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: Newly diagnosed multiple myeloma, preserved left ventricular ejection fraction

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Visit 1 (V1), prior to chemotherapy initiation

Secondary outcomes

1

Cardiac output reserve during exercise

Difference between cardiac output at rest and peak exercise

Time frame
Baseline (V1)
2

Heart rate reserve during exercise

Difference of heart rate between rest and peak exercise

Time frame
Baseline (V1)
3

Stroke volume reserve during exercise

Difference of stroke volume between peak exercise and rest

Time frame
Baseline (V1)
4

Minute ventilation to carbon dioxide production slope

Slope between minute ventilation and carbon dioxide production

Time frame
Baseline (V1)

Other outcomes

1

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.

Time frame
12 months (V3)
2

Change from baseline in cardiac biomarkers

Change of serum concentration in cardiac biomarkers (high-sensitivity troponin, NT-proBNP) from baseline (V1)

Time frame
Baseline (V1) to 3 months (V2) and 12 months (V3)
3

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

Time frame
Baseline (V1) to 3 months (V2) and 12 months (V3)

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