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

NCT07851493 | Recruiting

• 1 other identifier: 2026-323-S-KU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Behavior; Multiple Myeloma

Keywords

cardiopulmonary exercise testing; cardio-oncology; stress echocardiography; exercise phenotyping; cardiac magnetic resonance imaging

Outcome Measures

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.

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

Secondary Outcomes (10)

• Cardiac output reserve during exercise

  Baseline (V1)

• Heart rate reserve during exercise

  Baseline (V1)

• Stroke volume reserve during exercise

  Baseline (V1)

• Minute ventilation to carbon dioxide production slope

  Baseline (V1)

• Peak oxygen uptake

  Baseline (V1)

Other Outcomes (3)

• Association of baseline cardiac output to oxygen uptake with heart-failure hospitalisation, cardiovascular and all-cause mortality.

  12 months (V3)

• Change from baseline in cardiac biomarkers

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

• Change in quality of life

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

Study Arms (1)

Newly diagnosed multiple myeloma, preserved left ventricular ejection fraction

Patients with newly diagnosed, histologically or cytologically confirmed multiple myeloma who have not yet started chemotherapy, and whose resting echocardiogram shows preserved left ventricular ejection fraction (≥50%) with at most mild (grade I) diastolic dysfunction and no echocardiographic signs of clinically manifest cardiac involvement. All participants undergo the identical non-interventional diagnostic protocol (baseline cardiopulmonary exercise testing and stress echocardiography, cardiac magnetic resonance imaging, structured clinical follow-up at 3 and 12 months); there is no comparator/control group and no study intervention or treatment is assigned.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed multiple myeloma who have not yet initiated chemotherapy, recruited via the haemato-oncology outpatient clinics.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Preventive Sports Medicine and Sports Cardiology, TUM School of Medicine and Health, Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (5)

• Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.

  PMID: 36017568 BACKGROUND

• Landsteiner I, Foulkes SJ, Campain J, Camphausen CE, Zlotoff DA, Lewis GD, Haykowsky MJ. Reduced Exercise Capacity in Breast Cancer Compared to HFpEF: Mechanistic Insights From Invasive Exercise Testing. JACC CardioOncol. 2026 Feb;8(1):80-82. doi: 10.1016/j.jaccao.2025.12.002. Epub 2026 Jan 16.

  PMID: 41543471 BACKGROUND

• Pugliese NR, De Biase N, Conte L, Gargani L, Mazzola M, Fabiani I, Natali A, Dini FL, Frumento P, Rosada J, Taddei S, Borlaug BA, Masi S. Cardiac Reserve and Exercise Capacity: Insights from Combined Cardiopulmonary and Exercise Echocardiography Stress Testing. J Am Soc Echocardiogr. 2021 Jan;34(1):38-50. doi: 10.1016/j.echo.2020.08.015. Epub 2020 Oct 6.

  PMID: 33036818 BACKGROUND

• Canada JM, McCarty J, Jordan JH, Trankle CR, DeCamp K, West JD, Reynolds MA, Myers R, Sweat K, McGhee V, Arena R, Abbate A, Hundley WG. Simultaneous exercise stress cardiac magnetic resonance and cardiopulmonary exercise testing to elucidate the Fick components of aerobic exercise capacity: a feasibility and reproducibility study and pilot study in hematologic cancer survivors. Cardiooncology. 2023 Jul 10;9(1):31. doi: 10.1186/s40959-023-00182-1.

  PMID: 37430330 BACKGROUND

• Novo G, Stabile F, Di Lisi D, Madaudo C, Jaramillo S, Damiani F, Orilia C, Camilli M, Buccheri S, van Der Meer P, Galassi AR, Lyon AR. The impact of cardiac amyloidosis on patients with multiple myeloma: a systematic review and meta-analysis. Cardiooncology. 2026 Feb 10;12(1):32. doi: 10.1186/s40959-025-00435-1.

  PMID: 41664246 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Simon RDITU Wernhart, MD, PhD

  TUM - Technische Universität München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Wernhart, MD, PhD

CONTACT

491751830099; simon.wernhart@mri.tum.de

Sebastian Theurich, MD

CONTACT

Sebastian.Theurich@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy of the Clinical Director

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: October 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)