Clinical Evaluation of the Serum Free Light Chain Analysis
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|ClinicalTrials.gov Identifier: NCT01423344|
Recruitment Status : Unknown
Verified August 2011 by Charlotte Toftmann Hansen, University of Southern Denmark.
Recruitment status was: Recruiting
First Posted : August 25, 2011
Last Update Posted : August 25, 2011
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||February 2012|
- 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, ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|