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Clinical Evaluation of the Serum Free Light Chain Analysis
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
multiple myeloma, Free light chains
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
Summary
Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective.
A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.
Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.
Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.
A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.
Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.
Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:
- diagnosis of multiple myeloma
- abnormal serum free light chains
- medical needs of anti-myeloma therapy
- receiving standard anti-myeloma therapy
Exclusion Criteria:
- dialysis
- normal serum free light chains
- dementia
- diagnosis of multiple myeloma
- abnormal serum free light chains
- medical needs of anti-myeloma therapy
- receiving standard anti-myeloma therapy
Exclusion Criteria:
- dialysis
- normal serum free light chains
- dementia
Location
Department of Haematology, research unit
Odense C, Denmark
Status: Recruiting
Contact: Charlotte T Hansen, Fellow - 0045 24428085 - charlotte.toftmann.hansen@ouh.regionsyddanmark.dk
Start Date
February 2011
Completion Date
February 2012
Sponsors
Charlotte Toftmann Hansen
Source
University of Southern Denmark
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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