Multiple MyelomaNCT04300335
The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma
A study testing Individual Exercise and Group Exercise in people with Multiple Myeloma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Multiple myeloma is the second most common haematological cancer with a cancer incidence of around 500 new cases in Austria per year . Novel treatment methods have significantly increased the cancer-specific survival rate in patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Individual Exercise and Group Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2027to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Myeloma after primary Treatment
- Sufficient knowledge of the German language to being able to follow the study procedures
- Cardiologic-internal clearance for exercise
Who cannot join
- Fulfillment of absolute exclusion criteria of the cardiovascular system or on the musculoskeletal system with regard to physical trainability
- Insufficient language knowledge
- Cognitively unable to follow the course of the study
- Severe mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Effects of an Individualized Aerobic and Resistance Training Protocol for Patients Suffering From Multiple Myeloma With Varying Risk of Fall and Fracture - a Pilot Study
Multiple myeloma is the second most common haematological cancer with a cancer incidence of around 500 new cases in Austria per year . Novel treatment methods have significantly increased the cancer-specific survival rate in patients with multiple myeloma. For Austria, this means that 5- and 10-year survival rates rose from 32.1 to 46.4% and from 19.0 to 25.6% from the end of the 1980s to the end of the 2000s.
Longer survival is associated with the need to maintain independence and quality of life in the longer term. In this context, regular physical training has seen a significant increase in the importance of cancer in recent years.The guidelines of the American College of Sports Medicine still contain very general training recommendations for cancer patients. Either 150 minutes of moderate or 75 minutes of intensive endurance training per week are recommended, supplemented by at least two units of strengthening training and stretching exercises for the large muscle groups.
Read more
In a recent cross-sectional and pilot study with multiple myeloma patients that was carried out at the Clinic for Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna (EK 1725/2018), it was on the one hand identified that there was a discrepancy between these patients on the one hand has given actual and perceived risk of falling, and on the other hand it is concluded that training recommendations should be carried out separately in group and individual training according to the actual risk of falling and fracture.
The present project is the follow-up to this cross-sectional investigation. The aim is to examine the feasibility and effects of a structured, physical training program carried out over a period of 12 weeks on physical performance, quality of life, body composition and the risk of falling. The effects of patients with increased risk in individual training sessions are compared to those of lower risk patients in group training sessions. Furthermore, the study patients will be able to bring training partners with them to their own training units if available and for their own security. They are evaluated separately according to qualitative criteria.
Read the detailed description
The aim of this study is to investigate the feasibility and effectiveness of individualized training support for multiple myeloma patient populations divided into high and low risk according to their fall and fracture risk. The primary hypothesis is that multiple myeloma patients who meet the criteria for a high risk of falling and / or fracture can achieve equivalent adherence rates and training effects through individually compiled individual training, such as multiple myeloma patients with low risk of falling who conduct group training.
The adherence rates are recorded via attendance lists for training and video conferences as well as a training diary for independent training. To record the training effects, physical performance and functionality are measured and the quality of life, sexuality, depression, fatigue, sleep quality, work ability and risk of falling are assessed using standardized, validated questionnaires.
- Conditions
- Multiple Myeloma
- Being tested
- Individual Exercise, Group Exercise
- Keywords
- exercise, fracture risk
- Medical subject headings
- Multiple Myeloma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual ExerciseOther
Supervised body weight \& resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise
Group ExerciseOther
Supervised body weight \& resistance band resistance exercises in a Group setting plus home based aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| High Risk - Individual Exercise | Experimental | Patients who show an increased fracture risk and/or increased risk of fall in the screening assessments and are therefore allocated to an individualized personal training. Receives: Other: Individual Exercise |
| Low Risk - Group Exercise | Experimental | Patients who show neither increased fracture risk nor increased risk of fall in the screening assessments and are therefore allocated to the exercise group. Receives: Other: Group Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Adherence)
We hypothesize that the adherence of "High Risk Patients" to a personal, individualized exercise intervention is equal to that of "Low Risk Patients" performing group exercise.
Measured: Adherence rates through 12 weeks of exercise intervention program
Secondary outcomes (7)
VO2max
Maximum oxygen consumption in a cardiopulmonary exercise testing
Measured: Baseline + 12 weeks
Handgrip Strength (HGS)
Handgrip Dynamometer (JAMAR)
Measured: Baseline + 12 weeks
Six Minute Walk Test (6MWT)
Distance covered when walking as fast as possible in six minutes
Measured: Baseline + 12 weeks
Tinetti-Test/Performance Oriented Mobility Assessment (POMA)
Risk of Fall Assessment
Measured: Baseline + 12 weeks
Timed up and Go Test (TUG)
Risk of Fall Assessment
Measured: Baseline + 12 weeks
Bioimpedance Analysis (BiA)
Body Composition measurement measured with Nutribox (BiA)
Measured: Baseline + 12 weeks
Five Repetitions Sit-to-Stand Test (5STS)
Test for Lower Extremity Strength (time needed to stand up and sit down on a chair 5 times)
Measured: Baseline + 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Sep 2027 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Why it stopped: The study was not started because the necessary resources could not yet be secured after COVID-19, which was the reason for the initial interruption of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Individual exercise prescription (high fracture risk and/or high risk of fall patients) Group 2: Group exercise (low fracture risk and low risk of fall patients)
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Crevenna, Medical University of Vienna
- Investigators
- Richard Crevenna, Prof. MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300335
- Sponsor's protocol ID
- 2172/2019
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2020
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Radocha J, Hajek R, Brozova L, Pour L, Spicka I, Minarik J, Gregora E, Jungova A, Jelinek T, Heindorfer A, Sykora M, Maisnar V. Simplified novel prognostic score for real-life older adults with multiple myeloma-registry-based analysis. Ann Hematol. 2019 Apr;98(4):951-962. doi: 10.1007/s00277-018-3568-2. Epub 2018 Dec 11.
PubMed 30539278Warren JL, Harlan LC, Stevens J, Little RF, Abel GA. Multiple myeloma treatment transformed: a population-based study of changes in initial management approaches in the United States. J Clin Oncol. 2013 Jun 1;31(16):1984-9. doi: 10.1200/JCO.2012.46.3323. Epub 2013 Apr 8.
PubMed 23569317Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25.
PubMed 24157580Mock V, Pickett M, Ropka ME, Muscari Lin E, Stewart KJ, Rhodes VA, McDaniel R, Grimm PM, Krumm S, McCorkle R. Fatigue and quality of life outcomes of exercise during cancer treatment. Cancer Pract. 2001 May-Jun;9(3):119-27. doi: 10.1046/j.1523-5394.2001.009003119.x.
PubMed 11879296Crevenna R. Aspects of cancer rehabilitation: an Austrian perspective. Disabil Rehabil. 2020 Jan;42(1):1. doi: 10.1080/09638288.2018.1522554. Epub 2019 Jan 27. No abstract available.
PubMed 30686037Crevenna R. Cancer rehabilitation and palliative care--two important parts of comprehensive cancer care. Support Care Cancer. 2015 Dec;23(12):3407-8. doi: 10.1007/s00520-015-2977-1. Epub 2015 Oct 6. No abstract available.
PubMed 26441078Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
PubMed 20559064Cenik F, Keilani M, Hasenohrl T, Huber D, Stuhlpfarrer B, Pataraia A, Crevenna R. Relevant parameters for recommendations of physical activity in patients suffering from multiple myeloma : A pilot study. Wien Klin Wochenschr. 2020 Mar;132(5-6):124-131. doi: 10.1007/s00508-019-01582-z. Epub 2019 Nov 29.
PubMed 31784826
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of an Individualized Aerobic and Resistance Training Protocol for Patients Suffering From Multiple Myeloma With Varying Risk of Fall and Fracture - a Pilot Study
- ClinicalTrials.gov ID
- NCT04300335
- Acronym / sponsor ID
- 2172/2019
- Conditions
- Multiple Myeloma
- Keywords
- exercise, fracture risk
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was not started because the necessary resources could not yet be secured after COVID-19, which was the reason for the initial interruption of the study.
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Mar 2020 (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.
Multiple myeloma is the second most common haematological cancer with a cancer incidence of around 500 new cases in Austria per year . Novel treatment methods have significantly increased the cancer-specific survival rate in patients with multiple myeloma. For Austria, this means that 5- and 10-year survival rates rose from 32.1 to 46.4% and from 19.0 to 25.6% from the end of the 1980s to the end of the 2000s.
Longer survival is associated with the need to maintain independence and quality of life in the longer term. In this context, regular physical training has seen a significant increase in the importance of cancer in recent years.The guidelines of the American College of Sports Medicine still contain very general training recommendations for cancer patients. Either 150 minutes of moderate or 75 minutes of intensive endurance training per week are recommended, supplemented by at least two units of strengthening training and stretching exercises for the large muscle groups.
In a recent cross-sectional and pilot study with multiple myeloma patients that was carried out at the Clinic for Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna (EK 1725/2018), it was on the one hand identified that there was a discrepancy between these patients on the one hand has given actual and perceived risk of falling, and on the other hand it is concluded that training recommendations should be carried out separately in group and individual training according to the actual risk of falling and fracture.
The present project is the follow-up to this cross-sectional investigation. The aim is to examine the feasibility and effects of a structured, physical training program carried out over a period of 12 weeks on physical performance, quality of life, body composition and the risk of falling. The effects of patients with increased risk in individual training sessions are compared to those of lower risk patients in group training sessions. Furthermore, the study patients will be able to bring training partners with them to their own training units if available and for their own security. They are evaluated separately according to qualitative criteria.
Detailed description
The aim of this study is to investigate the feasibility and effectiveness of individualized training support for multiple myeloma patient populations divided into high and low risk according to their fall and fracture risk. The primary hypothesis is that multiple myeloma patients who meet the criteria for a high risk of falling and / or fracture can achieve equivalent adherence rates and training effects through individually compiled individual training, such as multiple myeloma patients with low risk of falling who conduct group training.
The adherence rates are recorded via attendance lists for training and video conferences as well as a training diary for independent training. To record the training effects, physical performance and functionality are measured and the quality of life, sexuality, depression, fatigue, sleep quality, work ability and risk of falling are assessed using standardized, validated questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Individual exercise prescription (high fracture risk and/or high risk of fall patients) Group 2: Group exercise (low fracture risk and low risk of fall patients)
| Arm | Type | Receives |
|---|---|---|
| High Risk - Individual Exercise | Experimental | Other: Individual ExercisePatients who show an increased fracture risk and/or increased risk of fall in the screening assessments and are therefore allocated to an individualized personal training. |
| Low Risk - Group Exercise | Experimental | Other: Group ExercisePatients who show neither increased fracture risk nor increased risk of fall in the screening assessments and are therefore allocated to the exercise group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple Myeloma after primary Treatment
- Sufficient knowledge of the German language to being able to follow the study procedures
- Cardiologic-internal clearance for exercise
Key exclusion criteria (4 listed)
- Fulfillment of absolute exclusion criteria of the cardiovascular system or on the musculoskeletal system with regard to physical trainability
- Insufficient language knowledge
- Cognitively unable to follow the course of the study
- Severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual ExerciseSupervised body weight \& resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise | Other | High Risk - Individual Exercise |
| Group ExerciseSupervised body weight \& resistance band resistance exercises in a Group setting plus home based aerobic exercise | Other | Low Risk - Group Exercise |
Primary outcome
Feasibility (Adherence)
Time frame: Adherence rates through 12 weeks of exercise intervention program
We hypothesize that the adherence of "High Risk Patients" to a personal, individualized exercise intervention is equal to that of "Low Risk Patients" performing group exercise.
7 secondary outcomes
VO2max
Time frame: Baseline + 12 weeks
Handgrip Strength (HGS)
Time frame: Baseline + 12 weeks
Six Minute Walk Test (6MWT)
Time frame: Baseline + 12 weeks
Tinetti-Test/Performance Oriented Mobility Assessment (POMA)
Time frame: Baseline + 12 weeks
Timed up and Go Test (TUG)
Time frame: Baseline + 12 weeks
Bioimpedance Analysis (BiA)
Time frame: Baseline + 12 weeks
Five Repetitions Sit-to-Stand Test (5STS)
Time frame: Baseline + 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 30539278Radocha J, Hajek R, Brozova L, Pour L, Spicka I, Minarik J, Gregora E, Jungova A, Jelinek T, Heindorfer A, Sykora M, Maisnar V. Simplified novel prognostic score for real-life older adults with multiple myeloma-registry-based analysis. Ann Hematol. 2019 Apr;98(4):951-962. doi: 10.1007/s00277-018-3568-2. Epub 2018 Dec 11.
- Background: PubMed 23569317Warren JL, Harlan LC, Stevens J, Little RF, Abel GA. Multiple myeloma treatment transformed: a population-based study of changes in initial management approaches in the United States. J Clin Oncol. 2013 Jun 1;31(16):1984-9. doi: 10.1200/JCO.2012.46.3323. Epub 2013 Apr 8.
- Background: PubMed 24157580Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25.
- Background: PubMed 11879296Mock V, Pickett M, Ropka ME, Muscari Lin E, Stewart KJ, Rhodes VA, McDaniel R, Grimm PM, Krumm S, McCorkle R. Fatigue and quality of life outcomes of exercise during cancer treatment. Cancer Pract. 2001 May-Jun;9(3):119-27. doi: 10.1046/j.1523-5394.2001.009003119.x.
- Background: PubMed 30686037Crevenna R. Aspects of cancer rehabilitation: an Austrian perspective. Disabil Rehabil. 2020 Jan;42(1):1. doi: 10.1080/09638288.2018.1522554. Epub 2019 Jan 27. No abstract available.
- Background: PubMed 26441078Crevenna R. Cancer rehabilitation and palliative care--two important parts of comprehensive cancer care. Support Care Cancer. 2015 Dec;23(12):3407-8. doi: 10.1007/s00520-015-2977-1. Epub 2015 Oct 6. No abstract available.
- Background: PubMed 20559064Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
- Background: PubMed 31784826Cenik F, Keilani M, Hasenohrl T, Huber D, Stuhlpfarrer B, Pataraia A, Crevenna R. Relevant parameters for recommendations of physical activity in patients suffering from multiple myeloma : A pilot study. Wien Klin Wochenschr. 2020 Mar;132(5-6):124-131. doi: 10.1007/s00508-019-01582-z. Epub 2019 Nov 29.
- Austrian Cancer Statistics Plasmocytoma/MyelomaLink provided by the sponsor.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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. This study is not recruiting at the moment.
Richard Crevenna, Prof. MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Exercise and Group Exercise in people with Multiple Myeloma, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 4 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: paused, as of the sponsor's last update on 9 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Adherence) (time frame: Adherence rates through 12 weeks of exercise intervention program). 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 NCT04300335, which also lists 8 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 9 Oct 2026.