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Sponsored by: |
Royal Marsden NHS Foundation Trust |
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Information provided by: | Royal Marsden NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00301275 |
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.
Study Type: | Observational |
Study Design: | Longitudinal, Random Sample, Prospective Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Surrey | |
Royal Marsden NHS trust | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Principal Investigator: | Ray Powles, FRCP, FRCpath | Royal Marsden NHS Foundation Trust |
Study ID Numbers: | 2123 |
Study First Received: | March 8, 2006 |
Last Updated: | March 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00301275 |
Health Authority: | United Kingdom: Research Ethics Committee |
Immunoproliferative Disorders Immunoglobulin Light Chains Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Antibodies Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Immunoglobulins Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |