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Assessing Free Immunoglobulin Light Chains in Patients With Myeloma
This study has been completed.
First Received: March 8, 2006   Last Updated: March 9, 2006   History of Changes
Sponsor: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00301275
  Purpose

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 Phase
Multiple Myeloma
Phase II

Study Type: Observational
Study Design: Longitudinal, Random Sample, Prospective Study

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Study Start Date: June 2002
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Multiple Myeloma patients in CR

Exclusion Criteria:

  • not being able to give consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301275

Locations
United Kingdom, Surrey
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
  More Information

No publications provided

Study ID Numbers: 2123
Study First Received: March 8, 2006
Last Updated: March 9, 2006
ClinicalTrials.gov Identifier: NCT00301275     History of Changes
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Immunoglobulin Light Chains
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 22, 2009