Clinical Evaluation of the Serum Free Light Chain Analysis

• Conditions: Multiple Myeloma

• Registration Number: NCT01423344
• Lead Sponsor: Charlotte Toftmann Hansen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Status Verified: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-24
• Last Update Submitted: 2011-08-24
• Study First Posted: 2011-08-25
• Last Update Posted: 2011-08-25
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein	1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,

Trial Locations

Locations (1)

Department of Haematology, research unit; 🇩🇰 Odense C, Denmark