Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301275
Status:
COMPLETED
Last Update Posted:
2006-03-10
First Post:
2006-03-08
Brief Title:
Assessing Free Immunoglobulin Light Chains in Patients With Myeloma
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None