Not Valid After February 22, 2019chain analysis. Annals of Clinical Biochemistry. 2013;50(Pt...

Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies Open Comment Period Information Packet

• References Included in the Data Extraction

• DRAFT Recommendations and Preliminary

Strength of Recommendations

• Grades for Strength of Recommendations

• Expert Panel Conflicts of Interest Disclosure

Report

Author(s): Arial, Gray, 10 pt, 1.5 Line Spacing

First name, Middle Initial, Last Name, MD, FCAP

Open Comment Period January 30-February 22, 2019

College of American Pathologists | 325 Waukegan Rd. | Northfield, IL 60093 | 800-323-4040 | cap.org

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• Project Scope• Study Selection Criteria


© 2019 College of American Pathologists. All rights reserved.

Project Scope

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DisclaimerTheinformation,data,anddraftrecommendationsprovidedbytheCollegeofAmericanPathologistsarepresentedforinformationalandpublicfeedbackpurposesonly.ThedraftrecommendationsandsupportingdocumentswillberemovedonMarch1,2019.Thedraftrecommendationsalongwiththepubliccommentsreceivedandcompletedevidencereviewwillbereassessedbytheexpertpanelinordertoformulatethefinalrecommendations.Thesedraftmaterialsshouldnotbestored,adapted,orredistributedinanymanner.

GuidelineScopeandCharter

GUIDELINE DRAFT TITLE: Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies

PROJECT CHARTER: The scope of the project is focused on pathology-related questions

related to the initial diagnosis of monoclonal gammopathies, beginning with how clinicians

should order for testing when monoclonal gammopathies are suspected and ending with how

pathologists should communicate the results of testing back to the clinician.

SCOPE: A primary goal of this guideline would be evidence-based recommendations for the

laboratory detection and initial diagnosis of monoclonal gammopathies. The scope includes

testing modalities in peripheral blood and urine, and excludes testing on bone marrow. The

scope will also include the reinforcement of the International Myeloma Working Group “Criteria

for Diagnosis of Multiple Myeloma” for testing and reporting.

BACKGROUND: The process for the detection of monoclonal gammopathies is highly

complex. To obtain an accurate diagnosis, diagnostic data must be compiled from several areas

of the laboratory (eg, total protein, immunoglobulin levels, gel or capillary electrophoreses

patterns).

Key Questions

What specimens are useful to detect MGs?

What are the appropriate tests needed to accurately detect and quantify MGs?

What information should be included in the laboratory order? And which laboratory testsare best used in which patients? What appropriate ancillary testing should berecommended?

TARGET AUDIENCE: The target audience of the evidence-based guideline is pathologists,

hematologists, clinicians, clinical laboratory directors, and clinical laboratory scientists.

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Study Selection Criteria

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DisclaimerTheinformation,data,anddraftrecommendationsprovidedbytheCollegeofAmericanPathologistsarepresentedforinformationalandpublicfeedbackpurposesonly.ThedraftrecommendationsandsupportingdocumentswillberemovedonMarch1,2019.Thedraftrecommendationsalongwiththepubliccommentsreceivedandcompletedevidencereviewwillbereassessedbytheexpertpanelinordertoformulatethefinalrecommendations.Thesedraftmaterialsshouldnotbestored,adapted,orredistributedinanymanner.

StudySelectionCriteria

Inclusion Criteria

1. Study population must consist of patients with clinical features raising consideration for

monoclonal gammopathies, including MGUS, MG of renal significance, light chain multiple

myeloma, non-secretory multiple myeloma, smoldering multiple myeloma, heavy chain disease,

AL amyloidosis, Waldenstrom Macroglobulinemia, solitary plasmacytoma, or POEMS syndrome.

2. Studies must evaluate either:

a. The use of serum or urine for accurate diagnosis of monoclonal gammopathy;

b. The ability of ancillary testing to diagnose and/or risk stratify patients with monoclonal

gammopathy.

3. Studies must include one of the following as primary outcomes:

a. Accuracy of diagnosis, including detection of monoclonal immunoglobulins, risk

stratification, rate of appropriate treatment, time to appropriate treatment;

b. Diagnostic test accuracy, including diagnostic sensitivity, specificity, positive predictive

value, and negative predictive value;

c. Patient survival outcomes, patient experience, quality of life outcomes, or complication

rates;

d. Concordance between intervention and the standard of care;

e. Appropriate utilization of samples, correct test selection, testing efficiency, or test turn-

around-time.

4. Studies must be peer-reviewed full-text articles

Exclusion Criteria

1. Letters

2. Commentaries

3. Editorials

4. Narrative Reviews

5. Case reports

6. Studies in animal models

7. In vitro studies

8. Consensus documents

9. Articles not in the English language

10. Abstracts

Date limits:

2008 - 2018

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References Included in the Data Extraction

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Disclaimer The information, data, and draft recommendations provided by the College of American Pathologists are presented for informational and public feedback purposes only. The draft recommendations and supporting documents will be removed on March 1, 2019. The draft recommendations along with the public comments received and completed evidence review will be reassessed by the expert panel in order to formulate the final recommendations. These draft materials should not be stored, adapted, or redistributed in any manner.

References Included in Data Extraction

Bakker AJ, Bierma-Ram A, Elderman-van der Werf C, Strijdhaftig ML, van Zanden JJ. Screening for M-proteinemia: serum protein electrophoresis and free light chains compared. Clinical Chemistry & Laboratory Medicine. 2009;47(12):1507-1511.

Bender LM, Cotten SW, Fedoriw Y, Willis MS, McCudden CR. Evaluation of digital images for identification and characterization of monoclonal immunoglobulins by immunofixation. Clinical Biochemistry. 2013;46(3):255-258.

Bochtler T, Hegenbart U, Heiss C, et al. Evaluation of the serum-free light chain test in untreated patients with AL amyloidosis. Haematologica. 2008;93(3):459-462.

Boer K, Deufel T. Quantitation of serum free light chains does not compensate for serum immunofixation only when screening for monoclonal gammopathies. Clinical Chemistry & Laboratory Medicine. 2009;47(9):1109-1115.

Boyle EM, Fouquet G, Guidez S, et al. IgA kappa/IgA lambda heavy/light chain assessment in the management of patients with IgA myeloma. Erratum appears in Cancer. 2015 Mar 1;121(5):800; PMID: 25855819. Cancer. 2014;120(24):3952-3957.

Brioli A, Giles H, Pawlyn C, et al. Serum free immunoglobulin light chain evaluation as a marker of impact from intraclonal heterogeneity on myeloma outcome. Blood. 2014;123(22):3414-3419.

Chae H, Han E, Yoo J, et al. Heavy/light chain assay as a biomarker for diagnosis and follow-up of multiple myeloma. Clinica Chimica Acta. 2018;479:7-13.

Cigliana G, Gulli F, Napodano C, et al. Serum free light chain quantitative assays: Dilemma of a biomarker. Journal of Clinical Laboratory Analysis. 2017;26:26.

Dejoie T, Attal M, Moreau P, Harousseau JL, Avet-Loiseau H. Comparison of serum free light chain and urine electrophoresis for the detection of the light chain component of monoclonal immunoglobulins in light chain and intact immunoglobulin multiple myeloma. Haematologica. 2016;101(3):356-362.

Dispenzieri A, Katzmann JA, Kyle RA, et al. Prevalence and risk of progression of light-chain monoclonal gammopathy of undetermined significance: a retrospective population-based cohort study. Erratum appears in Lancet. 2010 Jul 31;376(9738):332. Lancet. 2010;375(9727):1721-1728.

Dispenzieri A, Kyle RA, Katzmann JA, et al. Immunoglobulin free light chain ratio is an independent risk factor for progression of smoldering (asymptomatic) multiple myeloma. Blood. 2008;111(2):785-789.

Ellidag HY, Curek G, Eren E, Aydin O, Yilmaz N. The Cutoff Level for Urine Protein in Urine Immunofixation Electrophoresis. Clinical Laboratory. 2015;61(10):1525-1530.

Fulton RB, Fernando SL. Serum free light chain assay reduces the need for serum and urine immunofixation electrophoresis in the evaluation of monoclonal gammopathy. Annals of Clinical Biochemistry. 2009;46(Pt 5):407-412.

Gonzalez-Calle V, Davila J, Escalante F, et al. Bence Jones proteinuria in smoldering multiple myeloma as a predictor marker of progression to symptomatic multiple myeloma. Leukemia. 2016;30(10):2026-2031.

Heaney JLJ, Campbell JP, Griffin AE, et al. Diagnosis and monitoring for light chain only and oligosecretory myeloma using serum free light chain tests. British Journal of Haematology. 2017;178(2):220-230.

Hutchison CA, Plant T, Drayson M, et al. Serum free light chain measurement aids the diagnosis of myeloma in patients with severe renal failure. BMC Nephrology. 2008;9:11.

Jenner W, Klingberg S, Tate JR, Wilgen U, Ungerer JP, Pretorius CJ. Combined light chain immunofixation to detect monoclonal gammopathy: a comparison to standard electrophoresis in serum and urine. Clinical Chemistry & Laboratory Medicine. 2014;52(7):981-987.

Katzmann JA, Kyle RA, Benson J, et al. Screening panels for detection of monoclonal gammopathies. Clinical Chemistry. 2009;55(8):1517-1522.

Katzmann JA, Willrich MA, Kohlhagen MC, et al. Monitoring IgA multiple myeloma: immunoglobulin heavy/light chain assays. Clinical Chemistry. 2015;61(2):360-367. Not Vali

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Kim HS, Kim HS, Shin KS, et al. Clinical comparisons of two free light chain assays to immunofixation electrophoresis for detecting monoclonal gammopathy. BioMed Research International. 2014;2014:647238.

Kraj M, Kruk B, Lech-Maranda E, Warzocha K, Prochorec-Sobieszek M. High incidence of intact or fragmented immunoglobulin in urine of patients with multiple myeloma. Leukemia & Lymphoma. 2015;56(12):3348-3356.

Kubicki T, Dytfeld D, Baszczuk A, Wysocka E, Komarnicki M, Lewandowski K. Clinical usefulness of serum free light chains measurement in patients with multiple myeloma: comparative analysis of two different tests. Postepy Higieny i Medycyny do Swiadczalnej (Online). 2017;71(0):40-46.

Kyle RA, Larson DR, Therneau TM, et al. Clinical course of light-chain smouldering multiple myeloma (idiopathic Bence Jones proteinuria): a retrospective cohort study. The Lancet Haematology. 2014;1(1):e28-e36.

Landgren O, Kyle RA, Pfeiffer RM, et al. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009;113(22):5412-5417.

Lock RJ, Saleem R, Roberts EG, et al. A multicentre study comparing two methods for serum free light chain analysis. Annals of Clinical Biochemistry. 2013;50(Pt 3):255-261.

Ludwig H, Milosavljevic D, Zojer N, et al. Immunoglobulin heavy/light chain ratios improve paraprotein detection and monitoring, identify residual disease and correlate with survival in multiple myeloma patients. Erratum appears in Leukemia. 2013 Apr;27(4):996. Leukemia. 2013;27(1):213-219.

Magnano L, Fernandez de Larrea C, Elena M, et al. Prognostic Impact of Serum Heavy/Light Chain Pairs in Patients With Monoclonal Gammopathy of Undetermined Significance and Smoldering Myeloma: Long-Term Results From a Single Institution. Clinical lymphoma, myeloma & leukemia. 2016;16(6):e71-77.

Mahmood S, Wassef NL, Salter SJ, et al. Comparison of Free Light Chain Assays: Freelite and N Latex in Diagnosis, Monitoring, and Predicting Survival in Light Chain Amyloidosis. American Journal of Clinical Pathology. 2016;146(1):78-85.

McCudden CR, Mathews SP, Hainsworth SA, et al. Performance comparison of capillary and agarose gel electrophoresis for the identification and characterization of monoclonal immunoglobulins. American Journal of Clinical Pathology. 2008;129(3):451-458.

McTaggart MP, Lindsay J, Kearney EM. Replacing urine protein electrophoresis with serum free light chain analysis as a first-line test for detecting plasma cell disorders offers increased diagnostic accuracy and potential health benefit to patients. American Journal of Clinical Pathology. 2013;140(6):890-897.

Murray DL, Seningen JL, Dispenzieri A, et al. Laboratory persistence and clinical progression of small monoclonal abnormalities. American Journal of Clinical Pathology. 2012;138(4):609-613.

Palladini G, Jaccard A, Milani P, et al. Circulating free light chain measurement in the diagnosis, prognostic assessment and evaluation of response of AL amyloidosis: comparison of Freelite and N latex FLC assays. Clinical Chemistry & Laboratory Medicine. 2017;55(11):1734-1743.

Palladini G, Milani P, Foli A, et al. The impact of renal function on the clinical performance of FLC measurement in AL amyloidosis. Clinical Chemistry & Laboratory Medicine. 2016;54(6):939-945.

Palladini G, Russo P, Bosoni T, et al. Identification of amyloidogenic light chains requires the combination of serum-free light chain assay with immunofixation of serum and urine. Clinical Chemistry. 2009;55(3):499-504.

Park JW, Kim YK, Bae EH, Ma SK, Kim SW. Combined analysis using extended renal reference range of serum free light chain ratio and serum protein electrophoresis improves the diagnostic accuracy of multiple myeloma in renal insufficiency. Clinical Biochemistry. 2012;45(10-11):740-744.

Poisson J, Fedoriw Y, Henderson MP, et al. Performance evaluation of the Helena V8 capillary electrophoresis system. Clinical Biochemistry. 2012;45(9):697-699.

Prokaeva T, Spencer B, Sun F, et al. Immunoglobulin heavy light chain test quantifies clonal disease in patients with AL amyloidosis and normal serum free light chain ratio. Amyloid. 2016;23(4):214-220.

Rao M, Yu WW, Chan J, et al. Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias. Agency for Healthcare Research and Quality2012:08. Not Vali

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Roden AC, Lockington KS, Tostrud LJ, Katzmann JA. Urine protein electrophoresis and immunoelectrophoresis using unconcentrated or minimally concentrated urine samples. American Journal of Clinical Pathology. 2008;130(1):141-145.

Scudla V, Lochman P, Pika T, Minarik J, Zapletalova J, Bacovsky J. Relationship of differences in immunoglobulin heavy/light chain pairs (Hevylite), selected laboratory parameters and stratification systems in different immunochemical types of multiple myeloma. Biomedical Papers of the Medical Faculty of Palacky University in Olomouc, Czech Republic. 2016;160(1):84-93.

Smith J, Raines G, Schneider HG. A comparison between high resolution serum protein electrophoresis and screening immunofixation for the detection of monoclonal gammopathies in serum. Clinical Chemistry & Laboratory Medicine. 2018;56(2):256-263.

Snozek CL, Katzmann JA, Kyle RA, et al. Prognostic value of the serum free light chain ratio in newly diagnosed myeloma: proposed incorporation into the international staging system. Leukemia. 2008;22(10):1933-1937.

Sthaneshwar P, Nadarajan V, Maniam JA, Nordin N, Gin Gin G. Serum free light chains: diagnostic and prognostic value in multiple myeloma. Clinical Chemistry & Laboratory Medicine. 2009;47(9):1101-1107.

Turesson I, Kovalchik SA, Pfeiffer RM, et al. Monoclonal gammopathy of undetermined significance and risk of lymphoid and myeloid malignancies: 728 cases followed up to 30 years in Sweden. Blood. 2014;123(3):338-345.

Wang C, Su W, Cai QQ, et al. Prognostic value of serum heavy/light chain ratios in patients with POEMS syndrome. European Journal of Haematology. 2016;97(1):48-54.

Wang C, Su W, Zhang W, et al. Serum immunoglobulin free light chain and heavy/light chain measurements in POEMS syndrome. Annals of Hematology. 2014;93(7):1201-1206.

Wolff F, Debaugnies F, Rozen L, et al. Assessment of the diagnostic performances of IgA heavy and light chain pairs in patients with IgA monoclonal gammopathy. Clinical Biochemistry. 2013;46(1-2):79-84.

Xu B, Tang Y, Zhou J, Zhang P, Li H. Disease spectrum of abnormal serum free light chain ratio and its diagnostic significance. Oncotarget. 2017;8(47):82268-82279.

Mohammed N, Sudha Murthy S, Dattatreya PS. Serum free light chain ratio in correlation with serum protein electrophoresis in multiple myeloma patients from South India. International Journal of Pharma and Bio Sciences. 2015;6(1):B1074-B1080.

Korpysz M, Morawska M, Burska A, Donica H. Comparison of the free and total light chain assays in serum and urine samples with immunofixation electrophoresis for detecting monoclonal proteins in patients with monoclonal gammopathy. Current Issues in Pharmacy and Medical Sciences. 2014;27(3):165-170.

Korpysz M, Malecha-Jȩdraszek A, Donica H. Comparison of agarose gel and capillary electrophoresis for the characterization of serum monoclonal paraproteins. Current Issues in Pharmacy and Medical Sciences. 2013;26(3):299-304.

Korpysz M, Malecha-Jȩdraszek A, Donica H. Blood serum free light chain concentration vs. immunofixation results in patients with monoclonal gammapathy. Current Issues in Pharmacy and Medical Sciences. 2012;25(4):430-433.

Korpysz M, Malecha-Jȩdraszek A, Donica H, Wojtysiak-Duma B. Concentrations of free light chains determined by nephelometry and turbidimetry. Current Issues in Pharmacy and Medical Sciences. 2012;25(4):434-437.

Duranti F, Casciani S, Casalino P, et al. Preliminary evaluation of a new nephelometric reagent for the determination of serum free light chains. Biochimica Clinica. 2012;36(4):240-243.

Kraj M, Kruk B, Pogłód R, Warzocha K. Evaluation of IgG, IgA and IgM monoclonal and biclonal gammopathies by nephelometric measurement of individual immunoglobulin κ/λ ratios - Hevylite assay versus immunofixation. Acta Haematologica Polonica. 2011;42(2):257-271.

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DRAFT Recommendations and Preliminary Strength of Recommendations

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Monoclonal Gammopathies Draft Recommendations

Draft Recommendation Statement 1

Clinical care providers should order both serum protein electrophoresis (SPE) and serum free light chains (sFLC) assay for the initial detection of monoclonal protein in all patients with suspected monoclonal gammopathies (MG). Strength of Recommendation (SOR): Strong Draft Recommendation Statement 2

Laboratorians should confirm a SPE abnormality suspicious for a presence of a monoclonal gammopathy with serum immunofixation electrophoresis (IFE). SOR: Strong Draft Recommendation Statement 3

Laboratorians and/or clinical care providers should follow-up an abnormal sFLC ratio for the presence of a monoclonal gammopathy with a serum IFE. SOR: Conditional Draft Recommendation Statement 4

Clinical care providers should order SPE, sFLC, and urine IFE for the initial detection of monoclonal protein in all patients with suspected amyloid light chain (AL) amyloidosis. SOR: Strong Draft Recommendation Statement 5

Clinical care providers should NOT order heavy/light chain isotype assay (HLC) for initial detection of monoclonal protein in patients with suspected MG. SOR: Strong Draft Recommendation Statement 6

In patients with intact monoclonal proteins by SPE, laboratorians should use measurement of the M spike for quantification within the gamma region.

SOR: Conditional


In patients with intact monoclonal proteins by SPE, laboratorians should use total IgA for the quantification of the IgA monoclonal proteins outside the gamma region. SOR: Conditional Draft Recommendation Statement 8

Laboratorians should report both quantitative levels and kappa/lambda ratio when the sFLC assay is performed. SOR: Conditional Not Vali

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Monoclonal Gammopathies Draft Recommendations


Clinical care providers should use abnormal sFLC ratio, and ≥1.5 g/dL (15 g/L) value of intact monoclonal proteins as criteria for higher risk of progression in patients with monoclonal gammopathy. SOR: Conditional Draft Recommendation Statement 10

Clinical care providers may use the non-IgG isotype as a risk factor for progression to multiple myeloma or a B-cell lymphoproliferative disorder. SOR: Conditional Draft Recommendation Statement 11

Clinical care providers may use immunoparesis as a risk factor for progression to multiple myeloma or a B-cell lymphoproliferative disorder. SOR: Conditional Draft Recommendation Statement 12

Laboratorians should include a comment about the presence of immunoparesis in the SPE laboratory report. SOR: Conditional Draft Recommendation Statement 13

Clinical care providers should NOT use total/intact light chains for the quantification of monoclonal proteins in patients with suspected myeloma. SOR: Strong

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Grades for Quality of Evidence and Strength of Recommendations

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Disclaimer

The information, data, and draft recommendations provided by the College of American Pathologists are presented for informational and public feedback

purposes only.

The draft recommendations and supporting documents will be removed on March 1, 2019.

The draft recommendations along with the public comments received and completed evidence review will be reassessed by the expert panel in order to formulate

the final recommendations. These draft materials should not be stored, adapted, or redistributed in any manner.

Grades for Quality of Evidence and Strength of

Recommendations

Table 1. Grades for Quality of Evidence

Designation Description

High There is high confidence that available evidence reflects true effect. Further research

is very unlikely to change the confidence in the estimate of effect. Included studies

will be of high or intermediate quality.

Moderate There is moderate confidence that available evidence reflects true effect. Further

research is likely to have an important impact on the confidence in estimate of effect

and may change the estimate. Included studies will be of intermediate or low

quality.

Low There is limited confidence in the estimate of effect. The true effect may be

substantially different from the estimate of the effect. Included studies will be of low

quality.

Very Low There is very little confidence in the estimate of effect. The true effect is likely to be

substantially different from the estimate of effect. Any estimate of effect is very

uncertain. Included studies will be of low or very low quality.

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Disclaimer


purposes only.




Table 2. Grades for Strength of Recommendations

Designation Recommendation Rationale

Strong Recommendation Recommend for or against a particular

practice (Can include “must” or “should”)

Supported by high or moderate quality of evidence and

clear benefit that outweighs any harms

Conditional Recommendation Recommend for or against a particular

practice (Can include “should” or “may”)

Some limitations in quality of evidence (moderate to

low), balance of benefits and harms, values, or costs but

panel concludes that there is sufficient evidence and/or

benefit to inform a recommendation

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Evidence and Strength of

Recommendations

Disclaimer


purposes only.




Table 3. Crosswalk between CAP and GRADE Strength of Recommendations

CAP Designation GRADE Designation Rationale

Strong Recommendation Strong Recommendation • High strength of evidence

• Benefits over harms

• Implementable statement

Recommendation Conditional Recommendation • Moderate or low strength of evidence

• Benefits over harms, or balance


Expert Consensus Opinion Conditional Recommendation • Low or very low strength of evidence

• Balance of benefits and harms


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Evidence and Strength of

Recommendations



Expert Panel Conflicts of Interest Disclosure Report

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CONFIDENTIAL | Conflicts of Interest Report | 2018 Appointment Year

Conflicts of Interest

2018 Conflicts of Interest ReportCommittee: Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies—Expert Panel

Chair: David F. Keren, MD, FCAP, Co-chairMohammad Qasim Ansari, MD, Co-chair

Staff: Christina B. Ventura, MPH, MLS(ASCP)

Date: December 2018

Interest/Activity Type Entity Description (if applicable)

Shaji Kumar, MD

research grants Takeda

consulting fees or

advisory board

Takeda

Trial for Ixazomib and Bortezomib for treatment of plasma cell disorders and Myeloma Amyloidosis;PI for many investigator initiated trials that are supported by Takeda and also have participated in advisory boards and spoken at meetings that have Takeda support. Honorarium and research support go to Mayo.

Brea Lipe, MD

consulting fees or

advisory board

Celgene Consultant for Celgene . 2018-2018

David L. Murray, MD,PhD, FCAP

research grants The Binding Site

intellectual propertyrights

Mayo Clinic

Mayo has received an unrestricted research grant from The Binding Site to explore advancement of detection of monoclonalgammopathies by mass spectroscopy. 2016-2018Intellectual property rights with potential royalties on a mass spectrometric method to detect monoclonal gammopathies. 2016-Current/Ongoing

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CONFIDENTIAL | Conflicts of Interest Report | 2018 Appointment Year

Conflicts of Interest, continued

Main Employment:

Entity Description

Mohammad Qasim Ansari, MD, Co-chair Cleveland Veteran Administration Medical Center

Gregary Bocsi, DO, FCAP University of Colorado

Joan Etzell, MD, FCAP Sutter Health- Sutter Shared Laboratory

James D. Faix, MD, FCAP Montefiore Medical Center

David F Keren, MD, FCAP, Co-chair University of Michigan

Shaji Kumar, MD Mayo Clinic

Brea Lipe, MD University of Rochester

Christopher McCudden, PhD The Ottawa Hospital

Roberta Montgomery, BS, MLS Retired

David L. Murray, MD, PhD, FCAP Mayo Clinic

Alex J. Rai, PhD Columbia Irving University Medical Center

Teresita Cuyegkeng Redondo, MD, FCAP Saint Barnabas Medical Center

Brooke Billman, MLIS, AHIP College of American Pathologists

Christina Ventura, MPH, MLS(ASCP) College of American Pathologists

Lesley Souter, PhD Self-employed Methodologist

No COIs to Report:

Mohammad Qasim Ansari, MD, Co-chair Roberta Montgomery, BS, MLS

Gregary Bocsi, DO, FCAP Alex J. Rai, PhD

Joan Etzell, MD, FCAP Teresita Cuyegkeng Redondo, MD, FCAP

James D. Faix, MD, FCAP Brooke Billman, MLIS, AHIP

Shaji Kumar, MD Christina Ventura, MPH, MLS(ASCP)

David F. Keren, MD, FCAP, Co-chair Lesley Souter, PhD

Christopher McCudden, PhD

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