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Clinical Evaluation of the Serum Free Light Chain Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Charlotte Toftmann Hansen, University of Southern Denmark

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.

Condition or disease
Multiple Myeloma

Study Type : Observational
Estimated Enrollment : 30 participants
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
Study Start Date : February 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Primary Outcome Measures :
  1. 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
serum and urine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01423344

Contact: Charlotte T Hansen, Fellow 0045 24428085
Contact: Niels Abildgaard, Prof. 0045 65411637

Department of Haematology, research unit Recruiting
Odense C, Denmark, 5000
Contact: Charlotte T Hansen, Fellow    0045 24428085   
Principal Investigator: Charlotte T Hansen, Fellow         
Sponsors and Collaborators
Charlotte Toftmann Hansen
Principal Investigator: Charlotte T Hansen, Fellow Department of Haematology, research unit

Responsible Party: Charlotte Toftmann Hansen, Fellow, ph.d-stud, University of Southern Denmark Identifier: NCT01423344     History of Changes
Other Study ID Numbers: HFE-05-02
Danish Ethics comittee ( Other Identifier: S-VF-20050035 )
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011

Keywords provided by Charlotte Toftmann Hansen, University of Southern Denmark:
multiple myeloma
Free light chains

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases