Multiple Myeloma Bone LesionsGMMG-HD8-INDEXNCT07026799
Feasibility, Safety and Effectivity of an Exercise Intervention for Newly Diagnosed Multiple Myeloma Patients During Induction Therapy
A study testing Exercise in people with Multiple Myeloma Bone Lesions, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Physical exercise is an important supportive therapy for cancer patients, which improves quality of life and can effectively counteract the side effects of drug therapy. There is very little experience whether physical activity can also be performed safely by patients with malignant diseases that affect bone… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma Bone Lesions
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2023to 27 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed multiple myeloma
- Survival prognosis > 6 months
- ECOG status ≤ 3
- Age ≥18 years
- Patients who state that they want to carry out the training program at least 2 x/week and participate in the planned follow-up visits
- Ability to give informed consent
- Written consent to participate in the study
- Sufficient knowledge of written and spoken German
Who cannot join
- physical or mental limitation that would prevent participation in the training program or the planned follow-up visits.
- Carrying out a regular, intensive training program (min. 1h, 2x/week)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heidelberg University Hospital - GMMG Study Group
Heidelberg, 69120
About this study
Official title: Investigation of an Exercise Intervention for Multiple Myeloma Patients With Stable and Unstable Osteolytic Lesions During Induction Therapy.
Physical exercise is an important supportive therapy for cancer patients, which improves quality of life and can effectively counteract the side effects of drug therapy. There is very little experience whether physical activity can also be performed safely by patients with malignant diseases that affect bone stability. This applies in particular to patients with multiple myeloma, a disease characterized by a monoclonal proliferation of plasma cells in the bone marrow and often accompanied by severe bony destruction. Aim of this exploratory randomized controlled trial is to evaluate feasibility, safety and effectivity of an orthopaedic-guided exercise intervention during induction therapy in newly diagnosed multiple myeloma patients.
- Conditions
- Multiple Myeloma Bone Lesions
- Being tested
- Exercise, Control group
- Keywords
- orthopaedic evaluation of bone stability, Multiple myeloma, Physical exercise, Osteolysis
- Medical subject headings
- Multiple Myeloma, Motor Activity, Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Orthopedic consultation and home-based, individualized, structured resistance training during induction therapy.
Control groupOther
Orthopedic consultation and stretching exercises/walking. No resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Not described Receives: Other: Exercise |
| Control group | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue (MFI, Multidimensional Fatigue Inventory)
Measured: From enrollment to the end of stem cell transplantation (approximately one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start14 Apr 2023
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Jun 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 Myeloma Bone LesionsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Dapunt, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026799
- Sponsor's protocol ID
- S-165/2023
- Acronym
- GMMG-HD8-INDEX
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- 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
Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, Friedenreich CM, Wong RKS, Dhillon HM, Coyle V, Chua NS, Jonker DJ, Beale PJ, Haider K, Tang PA, Bonaventura T, Wong R, Lim HJ, Burge ME, Hubay S, Sanatani M, Campbell KL, Arthuso FZ, Turner J, Meyer RM, Brundage M, O'Brien P, Tu D, Booth CM; CHALLENGE Investigators. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer. N Engl J Med. 2025 Jul 3;393(1):13-25. doi: 10.1056/NEJMoa2502760. Epub 2025 Jun 1.
PubMed 40450658Nicol JL, Woodrow C, Burton NW, Mollee P, Nicol AJ, Hill MM, Skinner TL. Physical Activity in People with Multiple Myeloma: Associated Factors and Exercise Program Preferences. J Clin Med. 2020 Oct 13;9(10):3277. doi: 10.3390/jcm9103277.
PubMed 33066153Nicol JL, Hill MM, Burton NW, Skinner TL. Promoting exercise for patients with multiple myeloma: attitudes and practices of clinical haematologists. J Cancer Surviv. 2022 Jun;16(3):688-695. doi: 10.1007/s11764-021-01062-2. Epub 2021 Jun 11.
PubMed 34114194Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014 Oct;11(10):597-609. doi: 10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.
PubMed 25113839Christensen JF, Simonsen C, Hojman P. Exercise Training in Cancer Control and Treatment. Compr Physiol. 2018 Dec 13;9(1):165-205. doi: 10.1002/cphy.c180016.
PubMed 30549018
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of an Exercise Intervention for Multiple Myeloma Patients With Stable and Unstable Osteolytic Lesions During Induction Therapy.
- ClinicalTrials.gov ID
- NCT07026799
- Acronym / sponsor ID
- GMMG-HD8-INDEX / S-165/2023
- Conditions
- Multiple Myeloma Bone Lesions
- Keywords
- orthopaedic evaluation of bone stability, Multiple myeloma, Physical exercise, Osteolysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Jun 2026 (estimated)
- First posted
- 18 Jun 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.
Physical exercise is an important supportive therapy for cancer patients, which improves quality of life and can effectively counteract the side effects of drug therapy. There is very little experience whether physical activity can also be performed safely by patients with malignant diseases that affect bone stability. This applies in particular to patients with multiple myeloma, a disease characterized by a monoclonal proliferation of plasma cells in the bone marrow and often accompanied by severe bony destruction. Aim of this exploratory randomized controlled trial is to evaluate feasibility, safety and effectivity of an orthopaedic-guided exercise intervention during induction therapy in newly diagnosed multiple myeloma patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Exercise |
| Control group | Other | Other: Control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- newly diagnosed multiple myeloma
- Survival prognosis > 6 months
- ECOG status ≤ 3
- Age ≥18 years
- Patients who state that they want to carry out the training program at least 2 x/week and participate in the planned follow-up visits
Key exclusion criteria (2 listed)
- physical or mental limitation that would prevent participation in the training program or the planned follow-up visits.
- Carrying out a regular, intensive training program (min. 1h, 2x/week)
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 |
|---|---|---|
| ExerciseOrthopedic consultation and home-based, individualized, structured resistance training during induction therapy. | Other | Intervention group |
| Control groupOrthopedic consultation and stretching exercises/walking. No resistance training. | Other | Control group |
Primary outcome
Fatigue (MFI, Multidimensional Fatigue Inventory)
Time frame: From enrollment to the end of stem cell transplantation (approximately one year)
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 18 Jun 2025.
- Background: PubMed 40450658Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, Friedenreich CM, Wong RKS, Dhillon HM, Coyle V, Chua NS, Jonker DJ, Beale PJ, Haider K, Tang PA, Bonaventura T, Wong R, Lim HJ, Burge ME, Hubay S, Sanatani M, Campbell KL, Arthuso FZ, Turner J, Meyer RM, Brundage M, O'Brien P, Tu D, Booth CM; CHALLENGE Investigators. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer. N Engl J Med. 2025 Jul 3;393(1):13-25. doi: 10.1056/NEJMoa2502760. Epub 2025 Jun 1.
- Background: PubMed 33066153Nicol JL, Woodrow C, Burton NW, Mollee P, Nicol AJ, Hill MM, Skinner TL. Physical Activity in People with Multiple Myeloma: Associated Factors and Exercise Program Preferences. J Clin Med. 2020 Oct 13;9(10):3277. doi: 10.3390/jcm9103277.
- Background: PubMed 34114194Nicol JL, Hill MM, Burton NW, Skinner TL. Promoting exercise for patients with multiple myeloma: attitudes and practices of clinical haematologists. J Cancer Surviv. 2022 Jun;16(3):688-695. doi: 10.1007/s11764-021-01062-2. Epub 2021 Jun 11.
- Background: PubMed 25113839Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014 Oct;11(10):597-609. doi: 10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.
- Background: PubMed 30549018Christensen JF, Simonsen C, Hojman P. Exercise Training in Cancer Control and Treatment. Compr Physiol. 2018 Dec 13;9(1):165-205. doi: 10.1002/cphy.c180016.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Multiple Myeloma Bone Lesions, 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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2025. 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?
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?
Fatigue (MFI, Multidimensional Fatigue Inventory) (time frame: From enrollment to the end of stem cell transplantation (approximately one year)). 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 NCT07026799, 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 18 Jun 2025.