Clinical trial Recruiting at 1 site Observational Ages 18 to 99

Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

Official title: Exercise Phenotyping Prior to Chemotherapy Initiation in Patients With Newly Diagnosed Multiple Myeloma Without Resting Echocardiographic Signs of Cardiac Involvement

Run by Technical University of Munich · NCT07851493 · Data updated 2026-11-12

This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexAll
Enrollment80 (estimated)
SponsorTechnical University of Munich
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Munich, Bavaria)
StatusRecruiting
StartedSeptember 1, 2026
Main results expectedJanuary 2028
Study endsMarch 2029
Registry record updatedOctober 5, 2026
Trial IDNCT07851493 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with newly diagnosed multiple myeloma, not yet treated, and with preserved LVEF (≥50%) and at most mild diastolic dysfunction.

Probably not a fit

Patients with advanced cardiac disease, significant kidney impairment (eGFR <30), severe anemia, or contraindications to contrast agents are less likely to benefit or participate.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational pilot enrolling up to 80 adults with newly diagnosed multiple myeloma who have not yet started chemotherapy and have a preserved or near-normal resting echocardiogram. Participants undergo a comprehensive baseline assessment that includes medical history, labs, ECG, resting echocardiography, six-minute walk, and combined cardiopulmonary exercise testing with stress echocardiography plus cardiac MRI. The study aims to see if an exercise-induced cardiac limitation (CO/VO2 slope <5) is present despite normal rest findings and whether this marker correlates with subclinical myocardial changes and with heart-failure–related hospitalizations or mortality over 12 months. No interventional treatment is described; the project focuses on phenotyping exercise physiology and heart health in the pre-therapy stage. Results could inform future risk stratification and surveillance strategies in cardio-oncology for multiple myeloma patients.

Why it matters

Potential benefit: If successful, the trial could help identify patients at higher cardiac risk before chemotherapy, enabling closer monitoring or tailored treatment plans.

How similar studies have gone: This area is relatively novel in multiple myeloma, with limited prior data on exercise-based cardiac phenotyping; broader cardiotoxicity surveillance often relies on resting assessments rather than functional testing.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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
* Sufficient German or English language skills

Exclusion Criteria:

* 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
* Pregnancy or breastfeeding

Where it's running

  • Department of Preventive Sports Medicine and Sports Cardiology, TUM School of Medicine and Health, Klinikum rechts der Isar
    Munich, Bavaria, Germany
    Recruiting

Study contacts

  • Principal investigator: Simon RDITU Wernhart, MD, PhD — TUM - Technische Universität München
  • Study coordinator: Simon Wernhart, MD, PhD
  • Email: simon.wernhart@mri.tum.de
  • Phone: 491751830099

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.