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

NCT01006070 | Completed

• 1 other identifier: 0901Wolf
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; spinal disease

Outcome Measures

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

  1 year

Secondary Outcomes (2)

• 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

  1 year

• Identify x-ray predictors of future/pending vertebral fractures

  1 year

Study Arms (2)

Patients with existing spinal fractures

Myeloma patients with documented x-ray evidence of spinal fractures.

Procedure: kyphoplasty

Patients without spinal fractures

Myeloma patients with bony disease in the spine without existing fractures.

Procedure: kyphoplasty

Interventions

kyphoplasty PROCEDURE

surgical kyphoplasty

Also known as: balloon kyphoplasty

Patients with existing spinal fractures; Patients without spinal fractures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple myeloma patients with spinal lesions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Medtronics, Inc.: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Spinal Diseases

Interventions

Kyphoplasty

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; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jeffrey Wolf, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sigurd Berven, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Thomas Martin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

US (1)