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NCT00301275 Clinical Trial

Assessing Free Immunoglobulin Light Chains in Patients With Myeloma

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00301275
Other study ID # 2123
Secondary ID
Status Completed
Phase Phase 2
First received March 8, 2006
Last updated March 9, 2006
Start date June 2002
Est. completion date December 2005

Study information
Verified date March 2006
Source Royal Marsden NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Multiple Myeloma patients in CR

Exclusion Criteria:

- not being able to give consent

Study Design

Allocation: Random Sample, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Marsden NHS trust Sutton Surrey

Sponsors (1)
Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

See also
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