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Completed

NCT Number: NCT01006070

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Kyphoplasty

Procedure

surgical kyphoplasty

Other names: balloon kyphoplasty

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Identify x-ray predictors of future/pending vertebral fractures

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Medtronics, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2009
Registry last updated
Mar 21, 2012

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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