Rehabilitation Management for Patients with Multiple Myeloma

NCT06838065 | Completed

• 1 other identifier: 418/2022/OSS/AUSLRE
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma Bone Lesions; Multiple Myeloma (MM)

Keywords

multiple myeloma; skeletal-related events; rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  between 60 days before MM diagnosis and 24 months after MM diagnosis

Secondary Outcomes (7)

• Number pf patients who suffered pain and its location

  between 60 days before MM diagnosis and 60 days after MM diagnosis

• Number of patients with bone involvement at MM diagnosis

  between 60 days before MM diagnosis and 60 days after MM diagnosis

• Number of patients needing aids or orthoses

  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)

  between 60 days before MM diagnosis and 24 months after MM diagnosis

• Number of patients who received a Multiple Myeloma Multidisciplinary Team evaluation

  period including 60 days before MM diagnosis and 24 months after diagnosis

Study Arms (1)

Patients with a new diagnosis of Multiple Myeloma

who were managed by the Hematology Department in 2019, 2020, and 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

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

Reggio Emilia, 42123, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Stefania Fugazzaro, Physiatrist

  AUSL-IRCCS of Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 20, 2025
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)