Health-Related Quality of Life (QOL), Physical and Respiratory Function in Patients With Myeloma Affecting the Spine

March 19, 2012 updated by: University of California, San Francisco

Prospective Observation Study of Health-related QOL, Physical Function & Respiratory Function in Patients w/ Myeloma Affecting Spine: The Impact of Disease,Fractures & Effect of Vertebral Augmentation w/ Kyphoplasty

The purpose of this study is to create a prospective database of patients with myeloma affecting the spine. This database will define changes in health-related quality of life over time, and the effect of incident fractures and their treatment on specific measures of pain, physical function, pulmonary function, and future fractures. In 2008, the UCSF Myeloma Service was actively caring for 347 patients with myeloma, of which 150 patients had lytic lesions on radiographs, and 100 had a known vertebral fracture. This population, as well as any new myeloma patients, will serve as the source of the study population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The UCSF Adult Hematology Program maintains a data base of all patients with a diagnosis of multiple myeloma seen in the Clinic. As patients are treated, relapse, receive new treatment, are transplanted, or pass away, these data are entered into this Multiple Myeloma Data Base (MMDB).

The MMDB will be expanded to include parameters to identify those patients with myeloma affecting the spine. A recruitment letter will be sent to all patients in the MMDB identified as having myeloma affecting the spine asking if they would be interested in participating in this study.

Patients who agree to participate in the study will be given an appointment to meet with Dr. Wolf or Dr. Martin to discuss the study and if willing, to sign the informed consent document. They will have an exam and history taken that includes fracture history.

Patients who have signed consent will be sent for thoracic-lumbar spine films (unless they had prior spine films taken within the last 3 months). Those with normal films will not be eligible to be enrolled to the study. Those with abnormal spinal films will then be sent for MRI of the spine, pulmonary function testing, and meeting with Dr. R. Yonge who will administer the various QOL tests described below.

All eligible established and new patients will be invited to participate in the prospective study. Patients who sign the informed consent will be included in the prospective study. A minimum of 25 patients with vertebral fractures and 25 patients without fractures, will be observed to measure the impact of fractures on health-related quality of life. Study enrollment will be complete when 25 patients without a new fracture and 25 patients with a new fracture treated by balloon kyphoplasty have been enrolled.

Study Type

Observational

Enrollment (Actual)

50

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

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple myeloma patients with spinal lesions

Description

Inclusion Criteria:

  • Adults with a diagnosis of Multiple Myeloma and evidence of myelomatous lesions in the spine, including plasmacytomas, lytic lesions and fractures.

Exclusion Criteria:

  • Myeloma patients without evidence of bony lesions in the spine.

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
Intervention / Treatment
Patients with existing spinal fractures
Myeloma patients with documented x-ray evidence of spinal fractures.
Procedure: kyphoplasty
surgical kyphoplasty
Other Names:
  • balloon kyphoplasty
Patients without spinal fractures
Myeloma patients with bony disease in the spine without existing fractures.
Procedure: kyphoplasty
surgical kyphoplasty
Other Names:
  • balloon kyphoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify and prospectively study patients with myeloma affecting the spine, with or without compression fractures. Use standardized tools to assess health-related QOL, physical and respiratory function in these patients
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure: effect of pre-existing spinal fracture, prospectively measure effect of fractures and treatment on QOL, physical and respiratory function, and incidence of future fractures
Time Frame: 1 year
1 year
Identify x-ray predictors of future/pending vertebral fractures
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Medtronics, Inc.

Investigators

  • Principal Investigator: Jeffrey Wolf, MD, University of California, San Francisco

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

February 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (ESTIMATE)

November 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0901Wolf

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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