Clinical Evaluation of the Serum Free Light Chain Analysis
Recruitment status was Recruiting
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment|
- Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein [ Time Frame: 1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy, ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum and urine
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423344
|Contact: Charlotte T Hansen, Fellow||0045 firstname.lastname@example.org|
|Contact: Niels Abildgaard, Prof. dr.med||0045 email@example.com|
|Department of Haematology, research unit||Recruiting|
|Odense C, Denmark, 5000|
|Contact: Charlotte T Hansen, Fellow 0045 24428085 firstname.lastname@example.org|
|Principal Investigator: Charlotte T Hansen, Fellow|
|Principal Investigator:||Charlotte T Hansen, Fellow||Department of Haematology, research unit|