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

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• Point prevalence of a reduced cardiac output to oxygen uptake slope at baseline. — Baseline, Visit 1 (V1), prior to chemotherapy initiation
  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.

Trial sites (1)

More Technical University of Munich trials in Germany

Other trials for the same condition