Exercise BehaviorMM-ExerciseNCT07851493
Exercise Phenotyping Prior to Chemotherapy in Newly Diagnosed Multiple Myeloma (MM-Exercise)
An observational study of Exercise Behavior and Multiple Myeloma, run by Technical University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Exercise Behavior, Multiple Myeloma
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2026to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with newly diagnosed multiple myeloma who have not yet initiated chemotherapy, recruited via the haemato-oncology outpatient clinics.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian Theurich, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Preventive Sports Medicine and Sports Cardiology, TUM School of Medicine and Health, Klinikum rechts der Isar
Munich, Bavaria, 81675
Simon Wernhart, MD, PhD, 491751830099, simon.wernhart@mri.tum.de
Sebastian Theurich, MD, Sebastian.Theurich@med.uni-muenchen.de
About this study
Official title: Exercise Phenotyping Prior to Chemotherapy Initiation in Patients With Newly Diagnosed Multiple Myeloma Without Resting Echocardiographic Signs of Cardiac Involvement
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.
Read the detailed description
Cardiovascular complications are increasingly recognised as a major determinant of morbidity and mortality in multiple myeloma, whether related to concomitant amyloidosis, direct cardiotoxicity of modern anti-myeloma therapies (including proteasome inhibitors such as carfilzomib and bortezomib), or pre-existing cardiovascular comorbidity unmasked by treatment. Patients whose resting echocardiogram is unremarkable or only mildly abnormal are not currently considered to have clinically manifest cardiac involvement. Whether such patients nonetheless already harbour an exercise-inducible cardiac limitation that cannot be detected at rest has not previously been investigated. A reduced cardiac output to oxygen consumption slope (CO/VO2) has been proposed as a marker of central (cardiac), as opposed to peripheral (musculoskeletal), limitation of exercise capacity, but has never been evaluated in multiple myeloma. Guideline-based cardiotoxicity surveillance in oncology is built around resting-state pillars - cardiac biomarkers, resting echocardiography and, where indicated, cardiac magnetic resonance imaging (CMR) - none of which incorporates a functional, exercise-based assessment.
All clinical-functional baseline examinations (medical and sports history, laboratory testing, 12-lead electrocardiogram, ECG, resting echocardiography, 6-minute walk distance, and combined cardiopulmonary exercise testing with stress echocardiography, CPETecho) and CMR are performed. Resting echocardiography and CMR follow current European imaging guidelines. CPETecho is performed on a semi-supine bicycle ergometer with a ramp protocol aiming at 10-12 minutes of exercise duration to subjective (Borg scale >17) or metabolic (respiratory exchange ratio >1.05) exhaustion. Stress-echocardiographic variables are obtained at rest, at the first ventilatory threshold, and at peak exercise, and slopes (including CO/VO2) are calculated by linear regression through these three time-points. All study procedures are performed as diagnostic add-ons to the clinical routine work-up. The study includes no therapeutic intervention and no control/comparator group. Comparisons of interest (e.g. CO/VO2 slope <5 vs. ≥6, with values between 5 and 6 considered a physiological response to exercise) are made within the single study cohort.
Two protocol-defined, in-person clinical follow-up visits are performed for each patient, timed relative to that patient's own baseline visit (V1): V2 at 3 months and V3 at 12 months. Both comprise medical and sports history (including chart-documented ascertainment of morbidity, heart-failure hospitalisation and all-cause/cardiovascular mortality via hospital records), cardiac biomarkers, resting echocardiography, 6-minute walk distance, 12-lead ECG, and the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Karnofsky index. CMR and CPETecho are performed only once, at baseline. For patients who cannot attend V2 or V3 in person, or who transfer care outside the university network, morbidity, hospitalisation and vital status are ascertained by chart-based review of hospital records and, where necessary, structured telephone contact. Adverse events, defined as malignant ventricular arrhythmias during exercise, are documented at every visit. CPETecho and CMR analyses are performed blinded by an experienced investigator; CMR readings are performed independently by two blinded specialists, with a third expert adjudicating discordance. Statistical analysis is descriptive and exploratory (no confirmatory hypothesis testing): the primary endpoint is reported as a proportion with a 95% Clopper-Pearson confidence interval; continuous secondary endpoints are summarised as means ± SD or medians (IQR); correlations between CO/VO2 slope and CMR tissue parameters use Spearman rank correlation; group comparisons use the Mann-Whitney U test (continuous) or Fisher's exact test (categorical); the 12-month clinical outcome is described using Kaplan-Meier estimates. All analyses are hypothesis-generating (α=0.05, no correction for multiple testing).
- Conditions
- Exercise Behavior, Multiple Myeloma
- Keywords
- cardiopulmonary exercise testing, cardio-oncology, stress echocardiography, exercise phenotyping, cardiac magnetic resonance imaging
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Visit 1 (V1), prior to chemotherapy initiation
Secondary outcomes (10)
Cardiac output reserve during exercise
Difference between cardiac output at rest and peak exercise
Measured: Baseline (V1)
Heart rate reserve during exercise
Difference of heart rate between rest and peak exercise
Measured: Baseline (V1)
Stroke volume reserve during exercise
Difference of stroke volume between peak exercise and rest
Measured: Baseline (V1)
Minute ventilation to carbon dioxide production slope
Slope between minute ventilation and carbon dioxide production
Measured: Baseline (V1)
Peak oxygen uptake
Peak oxygen uptake related to body weight and minute
Measured: Baseline (V1)
Extent of late gadolinium enhancement on cardiac magnetic resonance imaging
Percentage of late gadolinium enhancement of the left ventricle on magnetic resonance imaging
Measured: Baseline (V1)
Myocardial oedema on T2-mapping
Myocardial oedema on T2-mapping during magnetic resonance imaging at baseline
Measured: Baseline (V1)
Native T1-time and extracellular volume on cardiac magnetic resonance imaging
Native T1-time and extracellular volume on cardiac magnetic resonance imaging at baseline
Measured: Baseline (V1)
Correlation between cardiac output to oxygen uptake slope and native T1-time and extracellular volume on magnetic resonance imaging
Correlation between cardiac output to oxygen uptake slope and native T1-time and extracellular volume on magnetic resonance imaging at baseline
Measured: Baseline (V1)
Incidence of malignant ventricular arrhythmias during combined cardiopulmonary exercise testing and stress echocardiography
Safety. Incidence of malignant ventricular arrhythmias (defined as sustained ventricular tachycardia, ventricular tachycardia with syncope, ventricular fibrillation, cardiopulmonary resuscitation) during combined cardiopulmonary exercise testing and stress echocardiography at baseline
Measured: Baseline (V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Sep 2026
- Primary completionJan 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exercise BehaviorStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Dr. rer. nat. Simon Wernhart, Technical University of Munich
- Investigators
- Simon RDITU Wernhart, MD, PhD, Principal investigator, TUM - Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851493
- Sponsor's protocol ID
- 2026-323-S-KU
- Acronym
- MM-Exercise
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information on the trial and procedures can be gained from the principal investigator upon reasonable request.
Publications
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.
PubMed 36017568Landsteiner 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.
PubMed 41543471Pugliese 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.
PubMed 33036818Canada 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.
PubMed 37430330Novo 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.
PubMed 41664246
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Phenotyping Prior to Chemotherapy Initiation in Patients With Newly Diagnosed Multiple Myeloma Without Resting Echocardiographic Signs of Cardiac Involvement
- ClinicalTrials.gov ID
- NCT07851493
- Acronym / sponsor ID
- MM-Exercise / 2026-323-S-KU
- Conditions
- Exercise Behavior, Multiple Myeloma
- Keywords
- cardiopulmonary exercise testing, cardio-oncology, stress echocardiography, exercise phenotyping, cardiac magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular complications are increasingly recognised as a major determinant of morbidity and mortality in multiple myeloma, whether related to concomitant amyloidosis, direct cardiotoxicity of modern anti-myeloma therapies (including proteasome inhibitors such as carfilzomib and bortezomib), or pre-existing cardiovascular comorbidity unmasked by treatment. Patients whose resting echocardiogram is unremarkable or only mildly abnormal are not currently considered to have clinically manifest cardiac involvement. Whether such patients nonetheless already harbour an exercise-inducible cardiac limitation that cannot be detected at rest has not previously been investigated. A reduced cardiac output to oxygen consumption slope (CO/VO2) has been proposed as a marker of central (cardiac), as opposed to peripheral (musculoskeletal), limitation of exercise capacity, but has never been evaluated in multiple myeloma. Guideline-based cardiotoxicity surveillance in oncology is built around resting-state pillars - cardiac biomarkers, resting echocardiography and, where indicated, cardiac magnetic resonance imaging (CMR) - none of which incorporates a functional, exercise-based assessment.
All clinical-functional baseline examinations (medical and sports history, laboratory testing, 12-lead electrocardiogram, ECG, resting echocardiography, 6-minute walk distance, and combined cardiopulmonary exercise testing with stress echocardiography, CPETecho) and CMR are performed. Resting echocardiography and CMR follow current European imaging guidelines. CPETecho is performed on a semi-supine bicycle ergometer with a ramp protocol aiming at 10-12 minutes of exercise duration to subjective (Borg scale >17) or metabolic (respiratory exchange ratio >1.05) exhaustion. Stress-echocardiographic variables are obtained at rest, at the first ventilatory threshold, and at peak exercise, and slopes (including CO/VO2) are calculated by linear regression through these three time-points. All study procedures are performed as diagnostic add-ons to the clinical routine work-up. The study includes no therapeutic intervention and no control/comparator group. Comparisons of interest (e.g. CO/VO2 slope <5 vs. ≥6, with values between 5 and 6 considered a physiological response to exercise) are made within the single study cohort.
Two protocol-defined, in-person clinical follow-up visits are performed for each patient, timed relative to that patient's own baseline visit (V1): V2 at 3 months and V3 at 12 months. Both comprise medical and sports history (including chart-documented ascertainment of morbidity, heart-failure hospitalisation and all-cause/cardiovascular mortality via hospital records), cardiac biomarkers, resting echocardiography, 6-minute walk distance, 12-lead ECG, and the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Karnofsky index. CMR and CPETecho are performed only once, at baseline. For patients who cannot attend V2 or V3 in person, or who transfer care outside the university network, morbidity, hospitalisation and vital status are ascertained by chart-based review of hospital records and, where necessary, structured telephone contact. Adverse events, defined as malignant ventricular arrhythmias during exercise, are documented at every visit. CPETecho and CMR analyses are performed blinded by an experienced investigator; CMR readings are performed independently by two blinded specialists, with a third expert adjudicating discordance. Statistical analysis is descriptive and exploratory (no confirmatory hypothesis testing): the primary endpoint is reported as a proportion with a 95% Clopper-Pearson confidence interval; continuous secondary endpoints are summarised as means ± SD or medians (IQR); correlations between CO/VO2 slope and CMR tissue parameters use Spearman rank correlation; group comparisons use the Mann-Whitney U test (continuous) or Fisher's exact test (categorical); the 12-month clinical outcome is described using Kaplan-Meier estimates. All analyses are hypothesis-generating (α=0.05, no correction for multiple testing).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with newly diagnosed multiple myeloma who have not yet initiated chemotherapy, recruited via the haemato-oncology outpatient clinics.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Point prevalence of a reduced cardiac output to oxygen uptake slope at baseline.
Time frame: 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.
10 secondary outcomes
Cardiac output reserve during exercise
Time frame: Baseline (V1)
Heart rate reserve during exercise
Time frame: Baseline (V1)
Stroke volume reserve during exercise
Time frame: Baseline (V1)
Minute ventilation to carbon dioxide production slope
Time frame: Baseline (V1)
Peak oxygen uptake
Time frame: Baseline (V1)
Extent of late gadolinium enhancement on cardiac magnetic resonance imaging
Time frame: Baseline (V1)
Myocardial oedema on T2-mapping
Time frame: Baseline (V1)
Native T1-time and extracellular volume on cardiac magnetic resonance imaging
Time frame: Baseline (V1)
Correlation between cardiac output to oxygen uptake slope and native T1-time and extracellular volume on magnetic resonance imaging
Time frame: Baseline (V1)
Incidence of malignant ventricular arrhythmias during combined cardiopulmonary exercise testing and stress echocardiography
Time frame: Baseline (V1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 36017568Lyon 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.
- Background: PubMed 41543471Landsteiner 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.
- Background: PubMed 33036818Pugliese 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.
- Background: PubMed 37430330Canada 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.
- Background: PubMed 41664246Novo 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.
- Individual participant dataSharing planned: No. Information on the trial and procedures can be gained from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Theurich, MD contact
Simon RDITU Wernhart, MD, PhD principal investigator
TUM - Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Behavior and Multiple Myeloma, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Wernhart, MD, PhD (491751830099, simon.wernhart@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence of a reduced cardiac output to oxygen uptake slope at baseline. (time frame: Baseline, Visit 1 (V1), prior to chemotherapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07851493, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.