Rehabilitation Management for Patients With Multiple Myeloma (FKTMM2022)

July 23, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with new Diagnosis of Multiple Myeloma in 2019,2020 or 2021 managed by the Hematology Department.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of even one inclusion criterion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with a new diagnosis of Multiple Myeloma
who were managed by the Hematology Department in 2019, 2020, and 2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
between 60 days before MM diagnosis and 24 months after MM diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Describe any bone involvement including which bones. Data will be collected from clinical database, considering the situation at diagnosis.
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
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.
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
The number of patients who received therapy with BMAs will be detected, considering the first 24 months from mm diagnosis.
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
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
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
Data will be collected from clinical database, in the period including 60 days before MM diagnosis and 24 months after diagnosis.
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

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

  • Content of rehabilitation sessions
  • Number of sessions
  • Treatment goals
  • Any adverse events
period including 60 days before MM diagnosis and 24 months after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Investigators

  • Principal Investigator: Stefania Fugazzaro, Physiatrist, AUSL-IRCCS of Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 418/2022/OSS/AUSLRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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