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Assessing Free Immunoglobulin Light Chains in Patients With Myeloma

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00301275
Collaborator
(none)
1
Location
42
Duration (Months)

Study Details

Study Description

Brief Summary

Multiple myeloma is a disorder in which malignant plasma cells accumulate in the bone marrow. These plasma cells produce an abnormal protein called paraprotein / M spike in the serum which can be serially monitored to assess the response of tumour on therapy. The paraprotein has a heavy chain which can be either IgG, IgA, IgM or IgD and a light chain which can be either kappa or lambda.

At present, these can be assessed by serum and urine electrophoresis (SPE and UPE). These techniques are relatively insensitive and poorly quantitative compared with other immunoassays for tumour markers.

The potential of serum free light chain (flc) measurement as a marker for myeloma has been recognised for some time. However, development of such assays has proved elusive, primarily due to the difficulty in developing assays that are both convenient to use and have the required specificity to measure flc in serum. Recently , the assay has been standardised and is in use. Its likely that the assessment of flc might be a sensitive marker of documenting complete remission in patients with myeloma. The aim of this study is to study the flc in patients with myeloma in complete remission (CR) to see if patients have CR documented by standard criteria- are the free light chains still positive and if so are they better markers of remission. The samples will be collected and tested in batches of 60 each.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Prospective
    Study Start Date :
    Jun 1, 2002
    Study Completion Date :
    Dec 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Inclusion Criteria:
      • Multiple Myeloma patients in CR
      Exclusion Criteria:
      • not being able to give consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Royal Marsden NHS trust Sutton Surrey United Kingdom SM2 5PT

      Sponsors and Collaborators

      • Royal Marsden NHS Foundation Trust

      Investigators

      • Principal Investigator: Ray Powles, FRCP, FRCpath, Royal Marsden NHS Foundation Trust

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00301275
      Other Study ID Numbers:
      • 2123
      First Posted:
      Mar 10, 2006
      Last Update Posted:
      Mar 10, 2006
      Last Verified:
      Mar 1, 2006
      Additional relevant MeSH terms:
      Multiple Myeloma

      Study Results

      No Results Posted as of Mar 10, 2006