Does anyone know what the clinical definition for Complete Response, Stringent Complete Response etc are?
I am a little confused after visiting my oncologist yesterday. I had a stem cell transplant in early June of this year. it went very well and I had minimal problems. Prior to the transplant I had responded very well to Velcade + dex. My most recent bone marrow biopsy in April olf this year showed my plasma level to be below 3%. I have not had monoclonal protein because my disease was heavy on the lambda light chain. My last free lite which I believe was in April also was within normal ranges as was the ratio of lambda to kappa.
Since the transplant I have not had a bone marrow biopsy or any updated free lite results. I asked my oncologist how he would define my level of remission and to my suprise he said very good partial despite the above blood work. I have had numerous bone lesions mainly in the central skeletal region with one fracture in the t5 which was treated early on with radiation.
Given my blood work would I not be considered in at least complete remission or does the amount of bone lesions play a major role in determining this?
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Mike M - Name: Mike M
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Jan 4th 2011
- Age at diagnosis: 51
Re: Complete response - definition?
Mike,
Exact criteria for each of the response types can be found here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627786/table/T5/
As a caution, though, these definitions have a lot of technical words, like immunofixation, soft tissue plasmacytomas, FLC ratio, etc.
Easier-to-understand definitions for complete response, partial response, and minimal response can be found on page 15 of the NCCN guidelines for myeloma patients:
http://www.nccn.com/images/patient-guidelines/pdf/myeloma.pdf
For instance, a complete response is defined by the NCCN as:
Disappearance of M-protein in the blood, less than 5 percent of plasma cells in the bone marrow, and no increase in size and number of bone lesions.
Exact criteria for each of the response types can be found here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627786/table/T5/
As a caution, though, these definitions have a lot of technical words, like immunofixation, soft tissue plasmacytomas, FLC ratio, etc.
Easier-to-understand definitions for complete response, partial response, and minimal response can be found on page 15 of the NCCN guidelines for myeloma patients:
http://www.nccn.com/images/patient-guidelines/pdf/myeloma.pdf
For instance, a complete response is defined by the NCCN as:
Disappearance of M-protein in the blood, less than 5 percent of plasma cells in the bone marrow, and no increase in size and number of bone lesions.
Re: Complete Response Definition
Hi, it sounds pretty promising to me! I would say to you happy times for a while, rest easier for a while and take good care of yourself.
Re: Complete response - definition?
Dear Beacon Staff and all,
Like Mike, I believe a handle on terminology is important to understanding multiple myeloma. Both the NIH and NCCN response criteria remain a little confusing to me as a lay person. Perhaps someone can help clarify the following questions:
1. This may seem a dumb question but NIH's Complete response criteria says "Negative Immunofixation". However, my copies of Lab Test Results give normal ranges for IGA as 70-400, IGG as 700-1600, IGM as 40-230. My personal results in my last labs were reported as IGA 16 (low), IGG 346 (low) and IGM <4 (low). These numbers are not negative but they are lower than normal. Lab comments include the statement that the results are "an apparent normal Immunofixation pattern". How does this fit the "negative" NIH terminology? Can you have a minus or "negative" IGA number [for example "IGA (-) 50"] or does "negative" refer to a abnormal range above normal while "positive" or "normal" would refer to a normal or less than normal range?
2. The NCCN Guidelines for Complete Response seems a little out of date as no definition of Mike's question regarding the definition of Stringent Complete Response is offered. Is there a lay version of the NIH definition for Complete Response broken down into the levels that oncologists report to patients?
3. Also, as I understand from Beacon reporting on July 22 under "New Response Type......", an even more stringent type of response, an Immunophenotypic Response, was recently identified in a Spanish trial as a further refinement of complete response prognosis. My oncologist says they can conduct the immunophenotypic response test in their own research facilities but not in an economically feasible way, no regional labs offer the test at a reasonable or any cost and the test refinement is so finely an improvement on stringent complete response criteria that the test is currently of very little to no use in treatment protocol (but the likely subject of further clinical research). Does the staff or anyone else have an insight or opinion into the future of the Spanish test?
Like Mike, I believe a handle on terminology is important to understanding multiple myeloma. Both the NIH and NCCN response criteria remain a little confusing to me as a lay person. Perhaps someone can help clarify the following questions:
1. This may seem a dumb question but NIH's Complete response criteria says "Negative Immunofixation". However, my copies of Lab Test Results give normal ranges for IGA as 70-400, IGG as 700-1600, IGM as 40-230. My personal results in my last labs were reported as IGA 16 (low), IGG 346 (low) and IGM <4 (low). These numbers are not negative but they are lower than normal. Lab comments include the statement that the results are "an apparent normal Immunofixation pattern". How does this fit the "negative" NIH terminology? Can you have a minus or "negative" IGA number [for example "IGA (-) 50"] or does "negative" refer to a abnormal range above normal while "positive" or "normal" would refer to a normal or less than normal range?
2. The NCCN Guidelines for Complete Response seems a little out of date as no definition of Mike's question regarding the definition of Stringent Complete Response is offered. Is there a lay version of the NIH definition for Complete Response broken down into the levels that oncologists report to patients?
3. Also, as I understand from Beacon reporting on July 22 under "New Response Type......", an even more stringent type of response, an Immunophenotypic Response, was recently identified in a Spanish trial as a further refinement of complete response prognosis. My oncologist says they can conduct the immunophenotypic response test in their own research facilities but not in an economically feasible way, no regional labs offer the test at a reasonable or any cost and the test refinement is so finely an improvement on stringent complete response criteria that the test is currently of very little to no use in treatment protocol (but the likely subject of further clinical research). Does the staff or anyone else have an insight or opinion into the future of the Spanish test?
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rmcarch - Name: robert cain
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 01/07/2011
- Age at diagnosis: 63
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