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Vincent S Rajkumar - One of the best experts on this subject based on the ideXlab platform.
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normalization of the serum free light chain flc ratio is associated with superior overall survival among myeloma patients achieving Immunofixation negative state results support incorporation of serum flc ratio in stringent cr definition
Blood, 2008Co-Authors: Shaji Kumar, Angela Dispenzieri, Dirk R Larson, Colin L Colby, Robert A Kyle, Morie A Gertz, Vincent S RajkumarAbstract:Background: Traditionally response to therapy in multiple myeloma (MM) is based on changes in the serum and urine monoclonal protein by immunoelectrophoresis. Immunofixation allows for detection of small amounts of monoclonal protein that cannot be quantitated on immunoelectrophoresis. Serum immunoglobulin free light chain (FLC) assay allows for detection of unbound kappa and lambda free light chain and has allowed disease measurement in patients with oligosecretory myelomas and can potentially allow detection of low levels of tumor burden, below the threshold of the standard tests. We examined this hypothesis in patients who had obtained a negative Immunofixation in serum and urine following treatment of their MM. Methods: For the purposes of the study, we included selected patients with MM who had measurable monoclonal (M) protein levels at baseline (defined as >1 gm/dL in the serum or >200 mg/24 hour in the urine or involved free light chain > 10 mg/dL) on protein electrophoresis; patients with non-secretory and oligo-secretory myeloma were excluded. We then identified patients who since 1995 had a negative Immunofixation in the serum and urine, all done at the same time (within 30 days of each other). Baseline demographics and clinical characteristics; date of diagnosis, last follow up, and follow up status; serum and urine M protein levels at diagnosis; and results of serum and urine Immunofixation, and serum free light chain (FLC) ratio within 30 days of the Immunofixation were all collected from the existing databases. Results: Eighty-four patients met the criteria for the study, all of whom had measurable disease at baseline and subsequently achieved negative Immunofixation in serum and urine. Among these, 46 patients (55%) also had a normal FLC ratio (K/L ratio; 0.26–1.65). Th median time from diagnosis to the documented Immunofixation was 7.5 months (range, 1–157). The median overall survival from diagnosis among those with a normal FLC ratio along with negative Immunofixation was not reached compared to 76 months for those with abnormal FLC ratio, P = 0.02. The median overall survival from the documentation of negative Immunofixation was not reached for the group with normal FLC ratio compared to 46.5 months for those with an abnormal FLC, P = 0.03. Conclusion: Attainment of a normal FLC ratio at the time of serum and urine Immunofixation negative status identifies a group of patients with better outcome. The presence of an abnormal FLC ratio likely represents persistence of the clonal population that is secreting none or very small amounts of monoclonal protein. The data presented here supports the inclusion of FLC measurements as part of response criteria for MM as has been done for the definition of stringent CR in the IMWG response criteria. ![Figure: ][1] Figure: Overall survival from diagnosis in patients with or with out a normal FLC ratio at the time of serum and urine Immunofixation. [1]: pending:yes
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elimination of the need for urine studies in the screening algorithm for monoclonal gammopathies by using serum Immunofixation and free light chain assays
Mayo Clinic Proceedings, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:OBJECTIVE To determine the relative diagnostic contribution of urine assays as part of the screening algorithm for monoclonal gammopathies. PATIENTS AND METHODS We identified 428 patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis of plasma cell dyscrasia who had also undergone serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis. The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. RESULTS The patients had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. All 428 had a monoclonal urine protein, 85.7% had an abnormal serum free light chain κ/λ ratio, 80.8% had an abnormal serum protein electrophoresis, and 93.5% had an abnormal serum Immunofixation result. All 3 serum assays were normal in only 2 patients, 1 of whom had monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria) and 1 whose urine sample contained an intact monoclonal immunoglobulin but whose serum and subsequent urine samples showed no evidence of a monoclonal gammopathy. CONCLUSION Discontinuation of urine studies and reliance on a diagnostic algorithm using only serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation) missed 2 (0.5%) of the 428 monoclonal gammopathies with urinary monoclonal proteins, and these 2 cases required no medical intervention.
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elimination of the need for urine studies during diagnostic studies of monoclonal gammopathies by the combined use of serum Immunofixation and serum free light chain assays
Blood, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:Due to the diagnostic sensitivity of serum free light chain quantitation for monoclonal light chain diseases, it has been suggested that urine assays no longer need be performed as part of the diagnostic algorithm for monoclonal proteins. We reviewed our experience to determine the relative diagnostic contribution of urine assays. Methods: Patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis who also had a serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis were identified (n = 428). The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. Results: The patients in this cohort had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. By definition of the cohort, all 428 had a monoclonal urine protein. 86% had an abnormal serum free light chain K/L ratio, 81% had an abnormal serum protein electrophoresis, and 94% had an abnormal serum Immunofixation. In only 2 patients, however, were all 3 serum assays normal. Both of these were patients with monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria). Conclusion: Discontinuation of urine studies and reliance on a diagnostic algorithm using solely serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation), missed 2 of the 428 monoclonal gammopathies (0.5 %) with urinary monoclonal proteins, and these 2 cases required no medical intervention.
Nicolaus Kroger - One of the best experts on this subject based on the ideXlab platform.
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monitoring serum free light chains in patients with multiple myeloma who achieved negative Immunofixation after allogeneic stem cell transplantation
Haematologica, 2007Co-Authors: Ulrike Mosbauer, Heike Schieder, Francis Ayuk, Axel R Zander, Michael Lioznov, Nicolaus KrogerAbstract:Monitoring of serum free immunoglobulin light chains (FLC) in 26 myeloma patients who achieved Immunofixation negativity after allografting showed a decrease of FLC at a median of 128 days before Immunofixation negativity. In patients who subsequently relapsed, a 25% increase of FLC was observed at a median of 98 days before Immunofixation positivity.
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serum free light chain flc assay in multiple myeloma patients who achieved negative Immunofixation after allogeneic stem cell transplantation
Blood, 2005Co-Authors: Ulrike Moesbauer, Heike Schieder, H Renges, Francis Ayuk, Axel R Zander, Nicolaus KrogerAbstract:The quantitative assay for free light chains [FLC] has been reported to be sensitive and specific for detecting and monitoring free light chain diseases such as multiple myeloma. To evaluate the sensitivity of FLC for monitoring patients in complete remission for early detection of relapse, the measurement of more than 250 serum free light chains were performed with the commercial available Freelite TM kit [Binding Site] in 26 patients who achieved complete remission with negative Immunofixation after dose reduced allogeneic stem cell transplantation. The patient groups were divided in those who remained Immunofixation negative [n=12, group 1] during follow-up of at least 1 year and those who had been Immunofixation negative but became positive during follow-up [n=9, group 2] and those who had achieved near complete remission with positive Immunofixation but then became Immunofixation negative during follow-up [n=5, group 3]. In group 1 the measuring of 105 FLC concentration and kappa/lambda ratio was performed in 12 patients. In 10 patients [83 %] free light concentration of kappa or lambda remained within the normal range during follow-up of more than 1 year. In 2 patients [17 %] kappa or lambda FLC concentration was above the normal range, but remained stable without any signs of increasing amount. Group 2 consisted of 9 patients who had been Immunofixation negative but became positive during follow-up. In all patients an increase of the corresponding free light chain could be observed in serum. In 4 patients a very close monitoring of Immunofixation and free light assay was performed and an at least 25 % increase of the free light concentration in serum was observed at a median of 97 days before immunfixation became positive. In group 3 five patients who had been Immunofixation positive became negative during follow-up. In all of the patients the free light concentration was within the range at time of negative Immunofixation. The corresponding free light concentration dropped down and reached normal level at a median of 38 days before the patients had achieved negativity of Immunofixation. These results suggest that serum free light chain assay allows monitoring of patients with complete remission and might detect early relapse before Immunofixation becomes positive. Thus, an early increase of free light chain assay in Immunofixation negative patients after allogeneic transplantation might be an useful guide for adoptive immunotherapy strategies to prevent clinical relapse.
Angela Dispenzieri - One of the best experts on this subject based on the ideXlab platform.
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normalization of the serum free light chain flc ratio is associated with superior overall survival among myeloma patients achieving Immunofixation negative state results support incorporation of serum flc ratio in stringent cr definition
Blood, 2008Co-Authors: Shaji Kumar, Angela Dispenzieri, Dirk R Larson, Colin L Colby, Robert A Kyle, Morie A Gertz, Vincent S RajkumarAbstract:Background: Traditionally response to therapy in multiple myeloma (MM) is based on changes in the serum and urine monoclonal protein by immunoelectrophoresis. Immunofixation allows for detection of small amounts of monoclonal protein that cannot be quantitated on immunoelectrophoresis. Serum immunoglobulin free light chain (FLC) assay allows for detection of unbound kappa and lambda free light chain and has allowed disease measurement in patients with oligosecretory myelomas and can potentially allow detection of low levels of tumor burden, below the threshold of the standard tests. We examined this hypothesis in patients who had obtained a negative Immunofixation in serum and urine following treatment of their MM. Methods: For the purposes of the study, we included selected patients with MM who had measurable monoclonal (M) protein levels at baseline (defined as >1 gm/dL in the serum or >200 mg/24 hour in the urine or involved free light chain > 10 mg/dL) on protein electrophoresis; patients with non-secretory and oligo-secretory myeloma were excluded. We then identified patients who since 1995 had a negative Immunofixation in the serum and urine, all done at the same time (within 30 days of each other). Baseline demographics and clinical characteristics; date of diagnosis, last follow up, and follow up status; serum and urine M protein levels at diagnosis; and results of serum and urine Immunofixation, and serum free light chain (FLC) ratio within 30 days of the Immunofixation were all collected from the existing databases. Results: Eighty-four patients met the criteria for the study, all of whom had measurable disease at baseline and subsequently achieved negative Immunofixation in serum and urine. Among these, 46 patients (55%) also had a normal FLC ratio (K/L ratio; 0.26–1.65). Th median time from diagnosis to the documented Immunofixation was 7.5 months (range, 1–157). The median overall survival from diagnosis among those with a normal FLC ratio along with negative Immunofixation was not reached compared to 76 months for those with abnormal FLC ratio, P = 0.02. The median overall survival from the documentation of negative Immunofixation was not reached for the group with normal FLC ratio compared to 46.5 months for those with an abnormal FLC, P = 0.03. Conclusion: Attainment of a normal FLC ratio at the time of serum and urine Immunofixation negative status identifies a group of patients with better outcome. The presence of an abnormal FLC ratio likely represents persistence of the clonal population that is secreting none or very small amounts of monoclonal protein. The data presented here supports the inclusion of FLC measurements as part of response criteria for MM as has been done for the definition of stringent CR in the IMWG response criteria. ![Figure: ][1] Figure: Overall survival from diagnosis in patients with or with out a normal FLC ratio at the time of serum and urine Immunofixation. [1]: pending:yes
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elimination of the need for urine studies in the screening algorithm for monoclonal gammopathies by using serum Immunofixation and free light chain assays
Mayo Clinic Proceedings, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:OBJECTIVE To determine the relative diagnostic contribution of urine assays as part of the screening algorithm for monoclonal gammopathies. PATIENTS AND METHODS We identified 428 patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis of plasma cell dyscrasia who had also undergone serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis. The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. RESULTS The patients had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. All 428 had a monoclonal urine protein, 85.7% had an abnormal serum free light chain κ/λ ratio, 80.8% had an abnormal serum protein electrophoresis, and 93.5% had an abnormal serum Immunofixation result. All 3 serum assays were normal in only 2 patients, 1 of whom had monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria) and 1 whose urine sample contained an intact monoclonal immunoglobulin but whose serum and subsequent urine samples showed no evidence of a monoclonal gammopathy. CONCLUSION Discontinuation of urine studies and reliance on a diagnostic algorithm using only serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation) missed 2 (0.5%) of the 428 monoclonal gammopathies with urinary monoclonal proteins, and these 2 cases required no medical intervention.
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elimination of the need for urine studies during diagnostic studies of monoclonal gammopathies by the combined use of serum Immunofixation and serum free light chain assays
Blood, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:Due to the diagnostic sensitivity of serum free light chain quantitation for monoclonal light chain diseases, it has been suggested that urine assays no longer need be performed as part of the diagnostic algorithm for monoclonal proteins. We reviewed our experience to determine the relative diagnostic contribution of urine assays. Methods: Patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis who also had a serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis were identified (n = 428). The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. Results: The patients in this cohort had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. By definition of the cohort, all 428 had a monoclonal urine protein. 86% had an abnormal serum free light chain K/L ratio, 81% had an abnormal serum protein electrophoresis, and 94% had an abnormal serum Immunofixation. In only 2 patients, however, were all 3 serum assays normal. Both of these were patients with monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria). Conclusion: Discontinuation of urine studies and reliance on a diagnostic algorithm using solely serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation), missed 2 of the 428 monoclonal gammopathies (0.5 %) with urinary monoclonal proteins, and these 2 cases required no medical intervention.
Dirk R Larson - One of the best experts on this subject based on the ideXlab platform.
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normalization of the serum free light chain flc ratio is associated with superior overall survival among myeloma patients achieving Immunofixation negative state results support incorporation of serum flc ratio in stringent cr definition
Blood, 2008Co-Authors: Shaji Kumar, Angela Dispenzieri, Dirk R Larson, Colin L Colby, Robert A Kyle, Morie A Gertz, Vincent S RajkumarAbstract:Background: Traditionally response to therapy in multiple myeloma (MM) is based on changes in the serum and urine monoclonal protein by immunoelectrophoresis. Immunofixation allows for detection of small amounts of monoclonal protein that cannot be quantitated on immunoelectrophoresis. Serum immunoglobulin free light chain (FLC) assay allows for detection of unbound kappa and lambda free light chain and has allowed disease measurement in patients with oligosecretory myelomas and can potentially allow detection of low levels of tumor burden, below the threshold of the standard tests. We examined this hypothesis in patients who had obtained a negative Immunofixation in serum and urine following treatment of their MM. Methods: For the purposes of the study, we included selected patients with MM who had measurable monoclonal (M) protein levels at baseline (defined as >1 gm/dL in the serum or >200 mg/24 hour in the urine or involved free light chain > 10 mg/dL) on protein electrophoresis; patients with non-secretory and oligo-secretory myeloma were excluded. We then identified patients who since 1995 had a negative Immunofixation in the serum and urine, all done at the same time (within 30 days of each other). Baseline demographics and clinical characteristics; date of diagnosis, last follow up, and follow up status; serum and urine M protein levels at diagnosis; and results of serum and urine Immunofixation, and serum free light chain (FLC) ratio within 30 days of the Immunofixation were all collected from the existing databases. Results: Eighty-four patients met the criteria for the study, all of whom had measurable disease at baseline and subsequently achieved negative Immunofixation in serum and urine. Among these, 46 patients (55%) also had a normal FLC ratio (K/L ratio; 0.26–1.65). Th median time from diagnosis to the documented Immunofixation was 7.5 months (range, 1–157). The median overall survival from diagnosis among those with a normal FLC ratio along with negative Immunofixation was not reached compared to 76 months for those with abnormal FLC ratio, P = 0.02. The median overall survival from the documentation of negative Immunofixation was not reached for the group with normal FLC ratio compared to 46.5 months for those with an abnormal FLC, P = 0.03. Conclusion: Attainment of a normal FLC ratio at the time of serum and urine Immunofixation negative status identifies a group of patients with better outcome. The presence of an abnormal FLC ratio likely represents persistence of the clonal population that is secreting none or very small amounts of monoclonal protein. The data presented here supports the inclusion of FLC measurements as part of response criteria for MM as has been done for the definition of stringent CR in the IMWG response criteria. ![Figure: ][1] Figure: Overall survival from diagnosis in patients with or with out a normal FLC ratio at the time of serum and urine Immunofixation. [1]: pending:yes
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elimination of the need for urine studies in the screening algorithm for monoclonal gammopathies by using serum Immunofixation and free light chain assays
Mayo Clinic Proceedings, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:OBJECTIVE To determine the relative diagnostic contribution of urine assays as part of the screening algorithm for monoclonal gammopathies. PATIENTS AND METHODS We identified 428 patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis of plasma cell dyscrasia who had also undergone serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis. The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. RESULTS The patients had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. All 428 had a monoclonal urine protein, 85.7% had an abnormal serum free light chain κ/λ ratio, 80.8% had an abnormal serum protein electrophoresis, and 93.5% had an abnormal serum Immunofixation result. All 3 serum assays were normal in only 2 patients, 1 of whom had monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria) and 1 whose urine sample contained an intact monoclonal immunoglobulin but whose serum and subsequent urine samples showed no evidence of a monoclonal gammopathy. CONCLUSION Discontinuation of urine studies and reliance on a diagnostic algorithm using only serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation) missed 2 (0.5%) of the 428 monoclonal gammopathies with urinary monoclonal proteins, and these 2 cases required no medical intervention.
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elimination of the need for urine studies during diagnostic studies of monoclonal gammopathies by the combined use of serum Immunofixation and serum free light chain assays
Blood, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:Due to the diagnostic sensitivity of serum free light chain quantitation for monoclonal light chain diseases, it has been suggested that urine assays no longer need be performed as part of the diagnostic algorithm for monoclonal proteins. We reviewed our experience to determine the relative diagnostic contribution of urine assays. Methods: Patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis who also had a serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis were identified (n = 428). The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. Results: The patients in this cohort had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. By definition of the cohort, all 428 had a monoclonal urine protein. 86% had an abnormal serum free light chain K/L ratio, 81% had an abnormal serum protein electrophoresis, and 94% had an abnormal serum Immunofixation. In only 2 patients, however, were all 3 serum assays normal. Both of these were patients with monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria). Conclusion: Discontinuation of urine studies and reliance on a diagnostic algorithm using solely serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation), missed 2 of the 428 monoclonal gammopathies (0.5 %) with urinary monoclonal proteins, and these 2 cases required no medical intervention.
Robert A Kyle - One of the best experts on this subject based on the ideXlab platform.
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normalization of the serum free light chain flc ratio is associated with superior overall survival among myeloma patients achieving Immunofixation negative state results support incorporation of serum flc ratio in stringent cr definition
Blood, 2008Co-Authors: Shaji Kumar, Angela Dispenzieri, Dirk R Larson, Colin L Colby, Robert A Kyle, Morie A Gertz, Vincent S RajkumarAbstract:Background: Traditionally response to therapy in multiple myeloma (MM) is based on changes in the serum and urine monoclonal protein by immunoelectrophoresis. Immunofixation allows for detection of small amounts of monoclonal protein that cannot be quantitated on immunoelectrophoresis. Serum immunoglobulin free light chain (FLC) assay allows for detection of unbound kappa and lambda free light chain and has allowed disease measurement in patients with oligosecretory myelomas and can potentially allow detection of low levels of tumor burden, below the threshold of the standard tests. We examined this hypothesis in patients who had obtained a negative Immunofixation in serum and urine following treatment of their MM. Methods: For the purposes of the study, we included selected patients with MM who had measurable monoclonal (M) protein levels at baseline (defined as >1 gm/dL in the serum or >200 mg/24 hour in the urine or involved free light chain > 10 mg/dL) on protein electrophoresis; patients with non-secretory and oligo-secretory myeloma were excluded. We then identified patients who since 1995 had a negative Immunofixation in the serum and urine, all done at the same time (within 30 days of each other). Baseline demographics and clinical characteristics; date of diagnosis, last follow up, and follow up status; serum and urine M protein levels at diagnosis; and results of serum and urine Immunofixation, and serum free light chain (FLC) ratio within 30 days of the Immunofixation were all collected from the existing databases. Results: Eighty-four patients met the criteria for the study, all of whom had measurable disease at baseline and subsequently achieved negative Immunofixation in serum and urine. Among these, 46 patients (55%) also had a normal FLC ratio (K/L ratio; 0.26–1.65). Th median time from diagnosis to the documented Immunofixation was 7.5 months (range, 1–157). The median overall survival from diagnosis among those with a normal FLC ratio along with negative Immunofixation was not reached compared to 76 months for those with abnormal FLC ratio, P = 0.02. The median overall survival from the documentation of negative Immunofixation was not reached for the group with normal FLC ratio compared to 46.5 months for those with an abnormal FLC, P = 0.03. Conclusion: Attainment of a normal FLC ratio at the time of serum and urine Immunofixation negative status identifies a group of patients with better outcome. The presence of an abnormal FLC ratio likely represents persistence of the clonal population that is secreting none or very small amounts of monoclonal protein. The data presented here supports the inclusion of FLC measurements as part of response criteria for MM as has been done for the definition of stringent CR in the IMWG response criteria. ![Figure: ][1] Figure: Overall survival from diagnosis in patients with or with out a normal FLC ratio at the time of serum and urine Immunofixation. [1]: pending:yes
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elimination of the need for urine studies in the screening algorithm for monoclonal gammopathies by using serum Immunofixation and free light chain assays
Mayo Clinic Proceedings, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:OBJECTIVE To determine the relative diagnostic contribution of urine assays as part of the screening algorithm for monoclonal gammopathies. PATIENTS AND METHODS We identified 428 patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis of plasma cell dyscrasia who had also undergone serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis. The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. RESULTS The patients had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. All 428 had a monoclonal urine protein, 85.7% had an abnormal serum free light chain κ/λ ratio, 80.8% had an abnormal serum protein electrophoresis, and 93.5% had an abnormal serum Immunofixation result. All 3 serum assays were normal in only 2 patients, 1 of whom had monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria) and 1 whose urine sample contained an intact monoclonal immunoglobulin but whose serum and subsequent urine samples showed no evidence of a monoclonal gammopathy. CONCLUSION Discontinuation of urine studies and reliance on a diagnostic algorithm using only serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation) missed 2 (0.5%) of the 428 monoclonal gammopathies with urinary monoclonal proteins, and these 2 cases required no medical intervention.
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elimination of the need for urine studies during diagnostic studies of monoclonal gammopathies by the combined use of serum Immunofixation and serum free light chain assays
Blood, 2006Co-Authors: Jerry A Katzmann, Angela Dispenzieri, Dirk R Larson, Robert A Kyle, Melissa R Snyder, Matthew F Plevak, Roshini S Abraham, John A Lust, Joseph L Melton, Vincent S RajkumarAbstract:Due to the diagnostic sensitivity of serum free light chain quantitation for monoclonal light chain diseases, it has been suggested that urine assays no longer need be performed as part of the diagnostic algorithm for monoclonal proteins. We reviewed our experience to determine the relative diagnostic contribution of urine assays. Methods: Patients with a monoclonal gammopathy and monoclonal urinary protein at initial diagnosis who also had a serum Immunofixation and serum free light chain quantitation within 30 days of diagnosis were identified (n = 428). The laboratory results for serum protein electrophoresis, serum Immunofixation, serum free light chain, urine protein electrophoresis, and urine Immunofixation were reviewed. Results: The patients in this cohort had diagnoses of multiple myeloma, primary amyloid, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytomas, and other less frequently detected monoclonal gammopathies. By definition of the cohort, all 428 had a monoclonal urine protein. 86% had an abnormal serum free light chain K/L ratio, 81% had an abnormal serum protein electrophoresis, and 94% had an abnormal serum Immunofixation. In only 2 patients, however, were all 3 serum assays normal. Both of these were patients with monoclonal gammopathy of undetermined significance (idiopathic Bence Jones proteinuria). Conclusion: Discontinuation of urine studies and reliance on a diagnostic algorithm using solely serum studies (protein electrophoresis, Immunofixation, and free light chain quantitation), missed 2 of the 428 monoclonal gammopathies (0.5 %) with urinary monoclonal proteins, and these 2 cases required no medical intervention.
