Clinical Evaluation of the Serum Free Light Chain Analysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Southern Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Charlotte Toftmann Hansen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01423344
First received: August 24, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 24, 2011
August 24, 2011
February 2011
February 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
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Clinical Evaluation of the Serum Free Light Chain Analysis
Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum and urine

Non-Probability Sample

Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs

Multiple Myeloma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Charlotte T Hansen, Fellow 0045 24428085 charlotte.toftmann.hansen@ouh.regionsyddanmark.dk
Contact: Niels Abildgaard, Prof. dr.med 0045 65411637 niels.abildgaard@ouh.regionsyddanmark.dk
Denmark
 
NCT01423344
HFE-05-02, Danish Ethics comittee
Yes
Charlotte Toftmann Hansen, University of Southern Denmark
Charlotte Toftmann Hansen
Not Provided
Principal Investigator: Charlotte T Hansen, Fellow Department of Haematology, research unit
University of Southern Denmark
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP