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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01423344

Enrollment

Registered

2011-08-25

Start date

2011-02-28

Completion date

2012-02-29

Last updated

2011-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

multiple myeloma, Free light chains

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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,

Countries

Denmark

Contacts

Primary ContactCharlotte T Hansen, Fellow

charlotte.toftmann.hansen@ouh.regionsyddanmark.dk0045 24428085

Backup ContactNiels Abildgaard, Prof. dr.med

niels.abildgaard@ouh.regionsyddanmark.dk0045 65411637

Outcome results