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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda USL Reggio Emilia - IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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