Multiple Myeloma Bone LesionsFKTMM2022NCT06838065
Rehabilitation Management for Patients With Multiple Myeloma
An observational study of Multiple Myeloma Bone Lesions and Multiple Myeloma (MM), run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
Multiple myeloma (MM) is the second most common blood cancer. Bone involvement is very common in these patients: it is estimated that between 80% and 90% will develop bone lesions during the course of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Bone Lesions, Multiple Myeloma (MM)
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 30 Sep 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with new Diagnosis of Multiple Myeloma in 2019,2020 or 2021 managed by the Hematology Department.
Who may be able to join
- New Diagnosis of Multiple Myeloma in 2019,2020 or 2021
- Older then 18 years
Who cannot join
- Absence of even one inclusion criterion
Trial locations and contacts
1 site in 1 country.
Italy1 site
AUSL-IRCCS of Reggio EmiliaOperational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia, Reggio Emilia, Emilia Romagna 42123
Reggio Emilia, 42123
About this study
Official title: Rehabilitation Management for Patients With Multiple Myeloma: a Retrospective Observational Study on Bone Fragility and Rehabilitation Needs in This Patient Population
Multiple myeloma (MM) is the second most common blood cancer. Bone involvement is very common in these patients: it is estimated that between 80% and 90% will develop bone lesions during the course of the disease. This represents a potential risk of fragility and pain, significantly impacting the patient's functional status and therefore worsening their quality of life. [1] The presence of bone lesions also represents a risk for the development of Skeletal-Related Events (SREs), which can include: pathological fractures, vertebral compression that causes spinal cord compression, and the need for surgery or radiotherapy to treat the bone lesions. It is important to monitor and manage SREs as they are associated with increased mortality.
With the improvement of treatments and increased survival rates, more and more patients require rehabilitation management, which includes therapeutic education, the prescription of orthoses/aids, and specific rehabilitation programs to address fatigue or cope with major events such as SREs. Also frequently needed are guidelines regarding safe physical activity and support for returning to work or resuming satisfying social participation.
In many MM patients, bone involvement represents a challenge for the rehabilitation specialist, who must be able to perform an accurate assessment of the risks and benefits of treatment to avoid exposing the patient to unnecessary risks or complications. Managing the patient within a multidisciplinary team of specialists can improve the accuracy of the overall assessment and therapeutic recommendations. The aim of our study is to retrospectively analyze patients with a new diagnosis of MM who were managed by the Hematology Department in 2019, 2020, and 2021, in order to describe and evaluate any SREs, as well as some clinical and rehabilitation data.
Read the detailed description
Multiple myeloma (MM) is the second most common hematologic malignancy and is characterized by the proliferation of malignant plasma cells within the bone marrow. Bone disease represents one of the most frequent clinical manifestations of MM, affecting approximately 80-90% of patients during the course of the disease. Osteolytic lesions are associated with pain, skeletal fragility, impaired mobility, reduced functional independence, and deterioration in quality of life.
Bone involvement increases the risk of skeletal-related events (SREs), including pathological fractures, vertebral compression resulting in spinal cord compression, and the need for surgery or radiotherapy to treat bone lesions. These events are associated with increased healthcare utilization, reduced functional outcomes, and poorer survival, highlighting the importance of their early identification and appropriate multidisciplinary management.
The improvement in therapeutic strategies has substantially increased the survival of patients with MM, making rehabilitation an increasingly important component of comprehensive patient care. Rehabilitation interventions may include therapeutic education, prescription of orthotic devices and assistive technologies, individualized exercise and rehabilitation programs to address fatigue and functional impairment, recommendations regarding safe physical activity, and support for returning to work and social participation. Because of the high risk of skeletal complications, rehabilitation planning requires careful assessment of the balance between potential benefits and risks. A multidisciplinary approach involving hematologists, rehabilitation specialists, and other healthcare professionals may optimize clinical decision-making and improve patient management.
This retrospective observational study aims to evaluate the occurrence of skeletal-related events in patients with newly diagnosed MM managed by the Hematology Department between January 2019 and December 2021. The study will also describe the clinical characteristics, bone involvement, rehabilitation needs, rehabilitation interventions, and functional outcomes of this patient population, providing real-world data that may support the optimization of multidisciplinary care pathways for patients with MM.
- Keywords
- multiple myeloma, skeletal-related events, rehabilitation
- 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 |
|---|---|---|
| Patients with a new diagnosis of Multiple Myeloma | who were managed by the Hematology Department in 2019, 2020, and 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experienced a Skeletal-Related Event (SRE) in the first 2 years from MM diagnosis
The Presence of SREs (pathological fractures, radiation to bone, bone surgery or spinal cord compression) will be recorded from clinical databases for each patient, considering the period including 60 days before MM diagnosis to 24 months after diagnosis.
Measured: SREs will be detected in the period including 60 days before MM diagnosis to 24 months after diagnosis
Number pf patients who underwent Hospitalization due to SREs
Record if the patient was hospitalized due to complications from SREs, considering this timeframe: between 60 days before MM diagnosis and 24 months after MM diagnosis.
Measured: between 60 days before MM diagnosis and 24 months after MM diagnosis
Number of patients reporting a pathological fracture, number of patients who needed radiation to bone, number of patients who underwent bone surgery, number of patients with spinal cord compression.
SREs are classified it as:
- pathological fractures
- spinal cord compression
- surgical stabilization of bone
- radiotherapy on bone This outcome will record how many patients experienced each of these SREs, in different moments of MM timeline.
We will specify if it is a:
- baseline SREs if patients experienced it within 60 days before MM diagnosis to 60 days after MM diagnosis
- early SREs if patients experienced it in the period included within 2 months after MM diagnosis up to 12 months
- late SREs if patients experienced it in the period included within 12 months after MM diagnosis up to 24 months
Measured: between 60 days before MM diagnosis and 24 months after MM diagnosis
Secondary outcomes (7)
Number pf patients who suffered pain and its location
Pain will be collected evaluating clinical database, considering the situation at MM diagnosis
Measured: between 60 days before MM diagnosis and 60 days after MM diagnosis
Number of patients with bone involvement at MM diagnosis
Describe any bone involvement including which bones. Data will be collected from clinical database, considering the situation at diagnosis.
Measured: between 60 days before MM diagnosis and 60 days after MM diagnosis
Number of patients needing aids or orthoses
In the first 24 months after diagnosis, the use of aids or orthoses will be collected from clinical database. If possible the duration (in months) of use of aids or orthoses will be collected.
Measured: between 60 days before MM diagnosis and 24 months after MM diagnosis
Number of patients who underwent therapy with zoledronic acid or other Bone Modifying Agents (BMAs)
The number of patients who received therapy with BMAs will be detected, considering the first 24 months from mm diagnosis.
Measured: between 60 days before MM diagnosis and 24 months after MM diagnosis
Number of patients who received a Multiple Myeloma Multidisciplinary Team evaluation
Data will be collected from clinical database, in the period including 60 days before MM diagnosis and 24 months after diagnosis. If a patient received more than 1 multidisciplinary team evaluation, this will be recorded
Measured: period including 60 days before MM diagnosis and 24 months after diagnosis
Number of patient who received a physiatric consultation
Data will be collected from clinical database, in the period including 60 days before MM diagnosis and 24 months after diagnosis.
Measured: period including 60 days before MM diagnosis and 24 months after diagnosis
Number of patients who received a Rehabilitation intervention
if the patient undergone to rehabilitation intervention, the study will describe:
- Content of rehabilitation sessions
- Number of sessions
- Treatment goals
- Any adverse events
Measured: period including 60 days before MM diagnosis and 24 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Sep 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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.
- 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
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stefania Fugazzaro, Physiatrist, Principal investigator, AUSL-IRCCS of Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838065
- Sponsor's protocol ID
- 418/2022/OSS/AUSLRE
- Acronym
- FKTMM2022
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Management for Patients With Multiple Myeloma: a Retrospective Observational Study on Bone Fragility and Rehabilitation Needs in This Patient Population
- ClinicalTrials.gov ID
- NCT06838065
- Acronym / sponsor ID
- FKTMM2022 / 418/2022/OSS/AUSLRE
- Keywords
- multiple myeloma, skeletal-related events, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Feb 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.
Multiple myeloma (MM) is the second most common blood cancer. Bone involvement is very common in these patients: it is estimated that between 80% and 90% will develop bone lesions during the course of the disease. This represents a potential risk of fragility and pain, significantly impacting the patient's functional status and therefore worsening their quality of life. [1] The presence of bone lesions also represents a risk for the development of Skeletal-Related Events (SREs), which can include: pathological fractures, vertebral compression that causes spinal cord compression, and the need for surgery or radiotherapy to treat the bone lesions. It is important to monitor and manage SREs as they are associated with increased mortality.
With the improvement of treatments and increased survival rates, more and more patients require rehabilitation management, which includes therapeutic education, the prescription of orthoses/aids, and specific rehabilitation programs to address fatigue or cope with major events such as SREs. Also frequently needed are guidelines regarding safe physical activity and support for returning to work or resuming satisfying social participation.
In many MM patients, bone involvement represents a challenge for the rehabilitation specialist, who must be able to perform an accurate assessment of the risks and benefits of treatment to avoid exposing the patient to unnecessary risks or complications. Managing the patient within a multidisciplinary team of specialists can improve the accuracy of the overall assessment and therapeutic recommendations. The aim of our study is to retrospectively analyze patients with a new diagnosis of MM who were managed by the Hematology Department in 2019, 2020, and 2021, in order to describe and evaluate any SREs, as well as some clinical and rehabilitation data.
Detailed description
Multiple myeloma (MM) is the second most common hematologic malignancy and is characterized by the proliferation of malignant plasma cells within the bone marrow. Bone disease represents one of the most frequent clinical manifestations of MM, affecting approximately 80-90% of patients during the course of the disease. Osteolytic lesions are associated with pain, skeletal fragility, impaired mobility, reduced functional independence, and deterioration in quality of life.
Bone involvement increases the risk of skeletal-related events (SREs), including pathological fractures, vertebral compression resulting in spinal cord compression, and the need for surgery or radiotherapy to treat bone lesions. These events are associated with increased healthcare utilization, reduced functional outcomes, and poorer survival, highlighting the importance of their early identification and appropriate multidisciplinary management.
The improvement in therapeutic strategies has substantially increased the survival of patients with MM, making rehabilitation an increasingly important component of comprehensive patient care. Rehabilitation interventions may include therapeutic education, prescription of orthotic devices and assistive technologies, individualized exercise and rehabilitation programs to address fatigue and functional impairment, recommendations regarding safe physical activity, and support for returning to work and social participation. Because of the high risk of skeletal complications, rehabilitation planning requires careful assessment of the balance between potential benefits and risks. A multidisciplinary approach involving hematologists, rehabilitation specialists, and other healthcare professionals may optimize clinical decision-making and improve patient management.
This retrospective observational study aims to evaluate the occurrence of skeletal-related events in patients with newly diagnosed MM managed by the Hematology Department between January 2019 and December 2021. The study will also describe the clinical characteristics, bone involvement, rehabilitation needs, rehabilitation interventions, and functional outcomes of this patient population, providing real-world data that may support the optimization of multidisciplinary care pathways for patients with MM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a new diagnosis of Multiple Myeloma | – | –who were managed by the Hematology Department in 2019, 2020, and 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with new Diagnosis of Multiple Myeloma in 2019,2020 or 2021 managed by the Hematology Department.
Key inclusion criteria (2 listed)
- New Diagnosis of Multiple Myeloma in 2019,2020 or 2021
- Older then 18 years
Key exclusion criteria (1 listed)
- Absence of even one inclusion criterion
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
Number of patients who experienced a Skeletal-Related Event (SRE) in the first 2 years from MM diagnosis
Time frame: SREs will be detected in the period including 60 days before MM diagnosis to 24 months after diagnosis
The Presence of SREs (pathological fractures, radiation to bone, bone surgery or spinal cord compression) will be recorded from clinical databases for each patient, considering the period including 60 days before MM diagnosis to 24 months after diagnosis.
Number pf patients who underwent Hospitalization due to SREs
Time frame: between 60 days before MM diagnosis and 24 months after MM diagnosis
Record if the patient was hospitalized due to complications from SREs, considering this timeframe: between 60 days before MM diagnosis and 24 months after MM diagnosis.
Number of patients reporting a pathological fracture, number of patients who needed radiation to bone, number of patients who underwent bone surgery, number of patients with spinal cord compression.
Time frame: between 60 days before MM diagnosis and 24 months after MM diagnosis
SREs are classified it as: * pathological fractures * spinal cord compression * surgical stabilization of bone * radiotherapy on bone This outcome will record how many patients experienced each of these SREs, in different moments of MM timeline. We will specify if it is a: * baseline SREs if patients experienced it within 60 days before MM diagnosis to 60 days after MM diagnosis * early SREs if patients experienced it in the period included within 2 months after MM diagnosis up to 12 months * late SREs if patients experienced it in the period included within 12 months after MM diagnosis up to 24 months
7 secondary outcomes
Number pf patients who suffered pain and its location
Time frame: between 60 days before MM diagnosis and 60 days after MM diagnosis
Number of patients with bone involvement at MM diagnosis
Time frame: between 60 days before MM diagnosis and 60 days after MM diagnosis
Number of patients needing aids or orthoses
Time frame: between 60 days before MM diagnosis and 24 months after MM diagnosis
Number of patients who underwent therapy with zoledronic acid or other Bone Modifying Agents (BMAs)
Time frame: between 60 days before MM diagnosis and 24 months after MM diagnosis
Number of patients who received a Multiple Myeloma Multidisciplinary Team evaluation
Time frame: period including 60 days before MM diagnosis and 24 months after diagnosis
Number of patient who received a physiatric consultation
Time frame: period including 60 days before MM diagnosis and 24 months after diagnosis
Number of patients who received a Rehabilitation intervention
Time frame: period including 60 days before MM diagnosis and 24 months after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Stefania Fugazzaro, Physiatrist principal investigator
AUSL-IRCCS of Reggio Emilia
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 Multiple Myeloma Bone Lesions and Multiple Myeloma (MM), run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 24 Jul 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients who experienced a Skeletal-Related Event (SRE) in the first 2 years from MM diagnosis (time frame: SREs will be detected in the period including 60 days before MM diagnosis to 24 months after diagnosis). The study lists 3 primary outcomes in all. 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 24 Jul 2026.