Clinical Evaluation of the Serum Free Light Chain Analysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Southern Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Charlotte Toftmann Hansen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01423344
First received: August 24, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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
Study Population

Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423344

Contacts
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

Locations
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         
Sponsors and Collaborators
Charlotte Toftmann Hansen
Investigators
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 September 18, 2014