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
2 other identifiers
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedAugust 25, 2011
August 1, 2011
1 year
August 24, 2011
August 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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,
Eligibility Criteria
Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs
You may qualify if:
- diagnosis of multiple myeloma
- abnormal serum free light chains
- medical needs of anti-myeloma therapy
- receiving standard anti-myeloma therapy
You may not qualify if:
- dialysis
- normal serum free light chains
- dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Haematology, research unit
Odense C, 5000, Denmark
Biospecimen
serum and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlotte T Hansen, Fellow
Department of Haematology, research unit
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Fellow, ph.d-stud
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 25, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
August 25, 2011
Record last verified: 2011-08