Multiple Myeloma Clinical Trial
Official title:
Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Haematology, research unit | Odense C |
| Lead Sponsor | Collaborator |
|---|---|
| Charlotte Toftmann Hansen |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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, | No |
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