Clinical trial NCT06838065: Rehabilitation Management for Patients with Multiple Myeloma
Official title: Rehabilitation Management for Patients with Multiple Myeloma: a Retrospective Observational Study on Bone Fragility and Rehabilitation Needs in This Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma Bone Lesions
Multiple Myeloma (MM)
Keywords: multiple myeloma
skeletal-related events
rehabilitation
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2025-02-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with new Diagnosis of Multiple Myeloma in 2019,2020 or 2021 managed by the Hematology Department.

Brief 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. 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 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 thus worsening their quality of life.

Furthermore, the presence of bone lesions represents a risk for the development of Skeletal-Related Events (SREs), which can include pathological fractures, vertebral compressions causing spinal cord compression, and the need for surgery or radiotherapy to treat bone lesions. It is important to monitor and manage SREs as they are associated with an increased risk of mortality.

With improvements in treatment and increased survival, more and more patients require rehabilitative care, which includes therapeutic education, the prescription of orthoses/aids, the implementation of specific rehabilitation programs to counter fatigue, or to address major events such as SREs. Equally important 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 professional, who must be able to make an accurate assessment of the risks and benefits of treatment to avoid exposing the patient to inappropriate risks or complications. Caring for 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 the years 2019, 2020, and 2021, in order to describe and assess any SREs, as well as some clinical and rehabilitative data.

Eligibility criteria: Inclusion Criteria:

* New Diagnosis of Multiple Myeloma in 2019,2020 or 2021
* Older then 18 years

Exclusion Criteria:

* Absence of even one inclusion criterion

Primary outcomes:
measure: Number of patients who experienced a Skeletal-Related Event (SRE) in the first 2 years from MM diagnosis
timeFrame: SREs will be detected in the period including 60 days before MM diagnosis to 24 months after diagnosis
measure: Number pf patients who underwent Hospitalization due to SREs
timeFrame: between 60 days before MM diagnosis and 24 months after MM diagnosis
measure: 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.
timeFrame: between 60 days before MM diagnosis and 24 months after MM diagnosis
Secondary outcomes:
measure: Number pf patients who suffered pain and its location
timeFrame: between 60 days before MM diagnosis and 60 days after MM diagnosis
measure: Number of patients with bone involvement at MM diagnosis
timeFrame: between 60 days before MM diagnosis and 60 days after MM diagnosis
measure: Number of patients needing aids or orthoses
timeFrame: between 60 days before MM diagnosis and 24 months after MM diagnosis
measure: Number of patients who underwent therapy with zoledronic acid or other Bone Modifying Agents (BMAs)
timeFrame: between 60 days before MM diagnosis and 24 months after MM diagnosis
measure: Number of patients who received a Multiple Myeloma Multidisciplinary Team evaluation
timeFrame: period including 60 days before MM diagnosis and 24 months after diagnosis
measure: Number of patient who received a physiatric consultation
timeFrame: period including 60 days before MM diagnosis and 24 months after diagnosis
measure: Number of patients who received a Rehabilitation intervention
timeFrame: period including 60 days before MM diagnosis and 24 months after diagnosis
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: AUSL-IRCCS of Reggio EmiliaOperational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia, Reggio Emilia, Emilia Romagna 42123
Study officials:
affiliation: AUSL-IRCCS of Reggio Emilia
name: Stefania Fugazzaro, Physiatrist
role: PRINCIPAL_INVESTIGATOR
References: