Clinical Evaluation of the Serum Free Light Chain Analysis
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Purpose
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 |
|---|
|
Multiple Myeloma |
| Study Type: | Observational |
| Study Design: | 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 |
- 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 ]
Biospecimen Retention: Samples Without DNA
serum and urine
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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
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
Contacts and Locations| 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 | |
| Department of Haematology, research unit | Recruiting |
| Odense C, Denmark, 5000 | |
| Contact: Charlotte T Hansen, Fellow 0045 24428085 charlotte.toftmann.hansen@ouh.regionsyddanmark.dk | |
| Principal Investigator: Charlotte T Hansen, Fellow | |
| Principal Investigator: | Charlotte T Hansen, Fellow | Department of Haematology, research unit |
More Information
No publications provided
| Responsible Party: | Charlotte Toftmann Hansen, Fellow, ph.d-stud, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT01423344 History of Changes |
| Other Study ID Numbers: | HFE-05-02, Danish Ethics comittee |
| Study First Received: | August 24, 2011 |
| Last Updated: | August 24, 2011 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by University of Southern Denmark:
|
multiple myeloma Free light chains |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013