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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


N/A
N/A
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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 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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Jeffrey Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

0901Wolf

NCT ID:

NCT01006070

Start Date:

February 2010

Completion Date:

March 2011

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • spinal disease
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UCSFSan Francisco, California  941430324