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Trial Title:
Clinical Evaluation of the Serum Free Light Chain Analysis
NCT ID:
NCT01423344
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Conditions: Keywords:
multiple myeloma
Free light chains
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Newly diagnosed patients with multiple myeloma, with medical needs and known patients
with multiple myeloma at there 1st relapse and medical needs
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Haematology, research unit
Address:
City:
Odense C
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Charlotte T Hansen, Fellow
Phone:
0045 24428085
Email:
charlotte.toftmann.hansen@ouh.regionsyddanmark.dk
Investigator:
Last name:
Charlotte T Hansen, Fellow
Email:
Principal Investigator
Start date:
February 2011
Completion date:
February 2012
Lead sponsor:
Agency:
Charlotte Toftmann Hansen
Agency class:
Other
Source:
University of Southern Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01423344
