Multiple Myeloma Bone LesionsSAPPHIRE-MMNCT07388147
Exercise Therapy for Multiple Myeloma Patients
A study testing Orthopedic consultation and rehabilitation by excercise therapy 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, as it improves quality of life in general and might mitigate the side effects of drug treatment. For patients with multiple myeloma in particular, significantly less evidence on the effectiveness of exercise therapy is available due to the fact… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma Bone Lesions
- What is being tested?
- Orthopedic consultation and rehabilitation by excercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2026to 31 Mar 2029
- 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 75 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
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
Heidelberg University Hospital - GMMG Study Group
Heidelberg, 69120
Dapunt, 06221 56 32765, ulrike.dapunt@med.uni-heidelberg.de
About this study
Official title: Structural Measures for Multiple Myeloma Patients to Improve Rehabilitation by Exercise Therapy
Physical exercise is an important supportive therapy for cancer patients, as it improves quality of life in general and might mitigate the side effects of drug treatment. For patients with multiple myeloma in particular, significantly less evidence on the effectiveness of exercise therapy is available due to the fact that this disease is associated with severe bone degradation which might affect bone stability. Advances in oncologic drug treatment have improved overall survival in multiple myeloma significantly. Therefore, there is an increased interest for recommendations on physical activity in this patient group. Due to uncertainties regarding safety and feasibility of exercise therapy in multiple myeloma, both patients and therapists often remain hesitant. Therefore, an orthopaedic outpatient clinic has been established at the Myeloma Center of Heidelberg University Hospital. Here, patients receive consultation on bone stability and individualized physical exercise plans. Based on the expertise gained at the orthopaedic outpatient clinic, the aim of this study is to establish and evaluate structural measures for improved rehabilitation in multiple myeloma and to integrate them into routine clinical care.
- Conditions
- Multiple Myeloma Bone Lesions
- Being tested
- Orthopedic consultation and rehabilitation by excercise therapy
- Keywords
- Implementation of structural measures, Rehabilitation, Exercise therapy, Multiple Myeloma, Bone lesions
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic consultation and rehabilitation by excercise therapyOther
All patients will receive a continuous orthopaedic consultation on bone stability and recommendations for exercise therapy during the different phases of systemic myeloma therapy. Thereby, structural measures to improve rehabilitation in multiple myeloma will be established and evaluated with the intention of integrating them into routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic consultation and exercise to evaluate structural measures and improve rehabilitation | Active comparator | Not described Receives: Other: Orthopedic consultation and rehabilitation by excercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical function
Results of the EORTC QLQ-C30 questionnaire ("Physical functioning" scale)
Measured: From enrollment to the end of induction therapy after 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
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
- NCT07388147
- Sponsor's protocol ID
- S-561/2025
- Acronym
- SAPPHIRE-MM
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * questionnaire results of each study participant * functional assessment of each study participant
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Measures for Multiple Myeloma Patients to Improve Rehabilitation by Exercise Therapy
- ClinicalTrials.gov ID
- NCT07388147
- Acronym / sponsor ID
- SAPPHIRE-MM / S-561/2025
- Conditions
- Multiple Myeloma Bone Lesions
- Keywords
- Implementation of structural measures, Rehabilitation, Exercise therapy, Multiple Myeloma, Bone lesions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 4 Feb 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.
Physical exercise is an important supportive therapy for cancer patients, as it improves quality of life in general and might mitigate the side effects of drug treatment. For patients with multiple myeloma in particular, significantly less evidence on the effectiveness of exercise therapy is available due to the fact that this disease is associated with severe bone degradation which might affect bone stability. Advances in oncologic drug treatment have improved overall survival in multiple myeloma significantly. Therefore, there is an increased interest for recommendations on physical activity in this patient group. Due to uncertainties regarding safety and feasibility of exercise therapy in multiple myeloma, both patients and therapists often remain hesitant. Therefore, an orthopaedic outpatient clinic has been established at the Myeloma Center of Heidelberg University Hospital. Here, patients receive consultation on bone stability and individualized physical exercise plans. Based on the expertise gained at the orthopaedic outpatient clinic, the aim of this study is to establish and evaluate structural measures for improved rehabilitation in multiple myeloma and to integrate them into routine clinical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic consultation and exercise to evaluate structural measures and improve rehabilitation | Active comparator | Other: Orthopedic consultation and rehabilitation by excercise therapy |
Who may qualify
- Ages
- 18 to 75 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 (1 listed)
- physical or mental limitation that would prevent participation in the training program or the planned follow-up visits
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 |
|---|---|---|
| Orthopedic consultation and rehabilitation by excercise therapyAll patients will receive a continuous orthopaedic consultation on bone stability and recommendations for exercise therapy during the different phases of systemic myeloma therapy. Thereby, structural measures to improve rehabilitation in multiple myeloma will be established and evaluated with the intention of integrating them into routine clinical care. | Other | Orthopedic consultation and exercise to evaluate structural measures and improve rehabilitation |
Primary outcome
Change in physical function
Time frame: From enrollment to the end of induction therapy after 18 weeks
Results of the EORTC QLQ-C30 questionnaire ("Physical functioning" scale)
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 4 Feb 2026.
- Individual participant dataSharing planned: Yes. * questionnaire results of each study participant * functional assessment of each study participant
Related trials for Multiple Myeloma Bone Lesions
Active, not recruiting
Feasibility, Safety and Effectivity of an Exercise Intervention for Newly Diagnosed Multiple Myeloma Patients During Induction Therapy
Multiple Myeloma Bone Lesions
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopedic consultation and rehabilitation by excercise therapy 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 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: opening soon, as of the sponsor's last update on 4 Feb 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 (06221 56 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?
Change in physical function (time frame: From enrollment to the end of induction therapy after 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.