Multiple MyelomaMyfallNCT07044427
Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients
A study testing Strength and balance training in combination with a treadmill-based pertubation intervention in people with Multiple Myeloma and Fall Risk Factors, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Approximately one third of the population over the age of 65 falls at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Fall Risk Factors, Strength Training Effects
- What is being tested?
- Strength and balance training in combination with a treadmill-based pertubation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2024to 30 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)
- ECOG status ≤ 3
- Age ≥18 years
- Patients who state that they want to carry out the training program at least 3 times/week and participate in the planned follow-up visits
- Ability to give informed consent
- Written consent to participate in the study
- Sufficient written and spoken German to complete the questionnaire
Who cannot join
- Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg, Baden Würtemberg, 69120
Ulrike Dapunt, Prof. Dr. med, +49 622156 32765, ulrike.dapunt@med.uni-heidelberg.de
About this study
Official title: Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma
Approximately one third of the population over the age of 65 falls at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be implemented.
The aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.
- Being tested
- Strength and balance training in combination with a treadmill-based pertubation intervention
- Keywords
- Multiple Myeloma, Fall risk, pertubation training, strength training, Balance
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and balance training in combination with a treadmill-based pertubation interventionOther
Patients receive a personalized home-based training plan with strength and balance exercises to be carried out three times a week for six months. In addition, treadmill-based pertubation training is carried out at 2 timepoints.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Other | Fall Prevention Receives: Other: Strength and balance training in combination with a treadmill-based pertubation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks
Patients will document the number of training sessions via an online training-app (Physiotec, Bad Wünnenberg, Germany). Feasibility is achieved if 48 of 72 possible training sessions were successfully completed.
Measured: From enrollement to the end of the training intervention at 6 months
Effectivity (fear of falling)
Fear of falling will be evaluated by a validated questionnaire (FES-I, Falls Efficacy Scale-Inernational). The questionnaire contains 16 items scored on a four-point scale (1=not at all concerned to 4=very concerned). Scores >23 indicate high concern about falling.
Measured: Evaluated at the beginning of the study and at the end of the study after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start2 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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 Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bethanien Krankenhaus gGmbH
- Responsible party
- Principal investigator, Ulrike Dapunt, University Hospital Heidelberg
- Investigators
- Dapunt, Study chair, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044427
- Sponsor's protocol ID
- S-045/2024
- Acronym
- Myfall
- Status last verified
- Jan 2026
- First submitted
- 10 Jun 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * questionnaire results collected for each individual * functional test results collected for each individual
Publications
Wildes TM, Fiala MA. Falls in older adults with multiple myeloma. Eur J Haematol. 2018 Mar;100(3):273-278. doi: 10.1111/ejh.13009. Epub 2018 Jan 8.
PubMed 29239009Wildes TM, Dua P, Fowler SA, Miller JP, Carpenter CR, Avidan MS, Stark S. Systematic review of falls in older adults with cancer. J Geriatr Oncol. 2015 Jan;6(1):70-83. doi: 10.1016/j.jgo.2014.10.003. Epub 2014 Oct 30.
PubMed 25454770Dapunt U, Ehret P, Paratte JL, Kuehl RM, Wiskemann J, Jager D, Muller-Tidow C, Raab MS, Goldschmidt H. A precision-based exercise program for patients with multiple myeloma. Eur J Haematol. 2023 Dec;111(6):930-937. doi: 10.1111/ejh.14106. Epub 2023 Sep 20.
PubMed 37727991Sattar S, Alibhai SM, Spoelstra SL, Fazelzad R, Puts MT. Falls in older adults with cancer: a systematic review of prevalence, injurious falls, and impact on cancer treatment. Support Care Cancer. 2016 Oct;24(10):4459-69. doi: 10.1007/s00520-016-3342-8. Epub 2016 Jul 22.
PubMed 27450557Pandya C, Magnuson A, Dale W, Lowenstein L, Fung C, Mohile SG. Association of falls with health-related quality of life (HRQOL) in older cancer survivors: A population based study. J Geriatr Oncol. 2016 May;7(3):201-10. doi: 10.1016/j.jgo.2016.01.007. Epub 2016 Feb 18.
PubMed 26907564
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07044427
- Acronym / sponsor ID
- Myfall / S-045/2024
- Keywords
- Multiple Myeloma, Fall risk, pertubation training, strength training, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Bethanien Krankenhaus gGmbH
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
Approximately one third of the population over the age of 65 falls at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be implemented.
The aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Other | Other: Strength and balance training in combination with a treadmill-based pertubation interventionFall Prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)
- ECOG status ≤ 3
- Age ≥18 years
- Patients who state that they want to carry out the training program at least 3 times/week and participate in the planned follow-up visits
- Ability to give informed consent
Key exclusion criteria (1 listed)
- Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.
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 |
|---|---|---|
| Strength and balance training in combination with a treadmill-based pertubation interventionPatients receive a personalized home-based training plan with strength and balance exercises to be carried out three times a week for six months. In addition, treadmill-based pertubation training is carried out at 2 timepoints. | Other | Exercise Intervention |
Primary outcome
Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks
Time frame: From enrollement to the end of the training intervention at 6 months
Patients will document the number of training sessions via an online training-app (Physiotec, Bad Wünnenberg, Germany). Feasibility is achieved if 48 of 72 possible training sessions were successfully completed.
Effectivity (fear of falling)
Time frame: Evaluated at the beginning of the study and at the end of the study after 6 months
Fear of falling will be evaluated by a validated questionnaire (FES-I, Falls Efficacy Scale-Inernational). The questionnaire contains 16 items scored on a four-point scale (1=not at all concerned to 4=very concerned). Scores >23 indicate high concern about falling.
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 22 Jan 2026.
- Background: PubMed 29239009Wildes TM, Fiala MA. Falls in older adults with multiple myeloma. Eur J Haematol. 2018 Mar;100(3):273-278. doi: 10.1111/ejh.13009. Epub 2018 Jan 8.
- Background: PubMed 25454770Wildes TM, Dua P, Fowler SA, Miller JP, Carpenter CR, Avidan MS, Stark S. Systematic review of falls in older adults with cancer. J Geriatr Oncol. 2015 Jan;6(1):70-83. doi: 10.1016/j.jgo.2014.10.003. Epub 2014 Oct 30.
- Background: PubMed 37727991Dapunt U, Ehret P, Paratte JL, Kuehl RM, Wiskemann J, Jager D, Muller-Tidow C, Raab MS, Goldschmidt H. A precision-based exercise program for patients with multiple myeloma. Eur J Haematol. 2023 Dec;111(6):930-937. doi: 10.1111/ejh.14106. Epub 2023 Sep 20.
- Background: PubMed 27450557Sattar S, Alibhai SM, Spoelstra SL, Fazelzad R, Puts MT. Falls in older adults with cancer: a systematic review of prevalence, injurious falls, and impact on cancer treatment. Support Care Cancer. 2016 Oct;24(10):4459-69. doi: 10.1007/s00520-016-3342-8. Epub 2016 Jul 22.
- Background: PubMed 26907564Pandya C, Magnuson A, Dale W, Lowenstein L, Fung C, Mohile SG. Association of falls with health-related quality of life (HRQOL) in older cancer survivors: A population based study. J Geriatr Oncol. 2016 May;7(3):201-10. doi: 10.1016/j.jgo.2016.01.007. Epub 2016 Feb 18.
- Individual participant dataSharing planned: Yes. * questionnaire results collected for each individual * functional test results collected for each individual
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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.
Dapunt study chair
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and balance training in combination with a treadmill-based pertubation intervention in people with Multiple Myeloma and Fall Risk Factors, run by University Hospital Heidelberg 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 7 inclusion and 1 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 22 Jan 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 Ulrike Dapunt, prof. Dr. med (+49 622156 32765, ulrike.dapunt@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks (time frame: From enrollement to the end of the training intervention at 6 months). The study lists 2 primary outcomes in all. 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 NCT07044427, 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 22 Jan 2026.