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NCT Number: NCT06838065

Rehabilitation Management for Patients With Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma Bone Lesions Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma (MM) Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AUSL-IRCCS of Reggio EmiliaOperational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia, Reggio Emilia, Emilia Romagna 42123

Reggio Emilia, 42123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Absence of even one inclusion criterion

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. Number pf patients who suffered pain and its location

    Time frame: between 60 days before MM diagnosis and 60 days after MM diagnosis

    Pain will be collected evaluating clinical database, considering the situation at MM diagnosis

  2. Number of patients with bone involvement at MM diagnosis

    Time frame: between 60 days before MM diagnosis and 60 days after MM diagnosis

    Describe any bone involvement including which bones. Data will be collected from clinical database, considering the situation at diagnosis.

  3. Number of patients needing aids or orthoses

    Time frame: between 60 days before MM diagnosis and 24 months after MM diagnosis

    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.

  4. 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

    The number of patients who received therapy with BMAs will be detected, considering the first 24 months from mm diagnosis.

  5. 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

    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

  6. Number of patient who received a physiatric consultation

    Time frame: period including 60 days before MM diagnosis and 24 months after diagnosis

    Data will be collected from clinical database, in the period including 60 days before MM diagnosis and 24 months after diagnosis.

  7. Number of patients who received a Rehabilitation intervention

    Time frame: period including 60 days before MM diagnosis and 24 months after diagnosis

    if the patient undergone to rehabilitation intervention, the study will describe:

    • Content of rehabilitation sessions
    • Number of sessions
    • Treatment goals
    • Any adverse events

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Rehabilitation Management for Patients With Multiple Myeloma: a Retrospective Observational Study on Bone Fragility and Rehabilitation Needs in This Patient Population

Acronym: FKTMM2022

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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