Test Catalog

Test Id : MSMRT

Mayo Algorithmic Approach for Stratification of Myeloma and Risk-Adapted Therapy Report, Bone Marrow

Useful For
Suggests clinical disorders or settings where the test may be helpful

Risk stratification of patients with multiple myeloma, which can assist in determining treatment and management decisions

 

Risk stratification of patients with newly diagnosed multiple myeloma

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
CSMRT MPCDS Pre-Analysis Cell Sorting, BM No No
MPCDS mSMART Eval, PCPDs, FISH No No
MPCDB Probe, Each Additional (MPCDS) No, (Bill Only) No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Based on the flow cytometric analysis and the presence of greater than or equal to 0.1% monotypic plasma cells, the pre-analysis cell sorting and fluorescence in situ hybridization (FISH) for plasma cell proliferative disorders will be performed at an additional charge.

 

This test is designed for diagnostic specimens. If a request for testing has been submitted within 12 months of a complete and informative plasma cell proliferative disorder FISH study, the current test request will be canceled.

 

For more information see Multiple Myeloma: Laboratory Screening.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Flow Cytometry/DNA Content/Cell Cycle Analysis

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

mSMART Algorithmic Testing, BM

Aliases
Lists additional common names for a test, as an aid in searching

Labeling Index

Myeloma Staging

PC Proliferation

PCLIP

Plasma Cell Labeling Index (PCLI)

Plasma Cell Staging

+1q or CKS1B

+3/+7

+9/+15

-13 (monosomy 13)

13q- / -13 (13q deletion) or RB1

17p- (17p deletion) or TP53

IGH (14q32) rearrangement

Monoclonal Gammopathy of Unknown Significance (MGUS)

Multiple Myeloma

MYC (8q24.1) rearrangement

Plasma Cell Leukemia

t(11;14)-CCND1/IGH

t(14;16)-IGH/MAF

t(14;20)-IGH/MAFB

t(4;14)-FGFR3/IGH

t(6;14)-CCND3/IGH

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Based on the flow cytometric analysis and the presence of greater than or equal to 0.1% monotypic plasma cells, the pre-analysis cell sorting and fluorescence in situ hybridization (FISH) for plasma cell proliferative disorders will be performed at an additional charge.

 

This test is designed for diagnostic specimens. If a request for testing has been submitted within 12 months of a complete and informative plasma cell proliferative disorder FISH study, the current test request will be canceled.

 

For more information see Multiple Myeloma: Laboratory Screening.

Specimen Type
Describes the specimen type validated for testing

Bone Marrow

Ordering Guidance

This test should be ordered at diagnosis, for follow-up of a plasma cell neoplasm (plasma cell proliferative disorder), or for a known relapsing patient of multiple myeloma and when MPCDS / mSMART, Plasma Cell Proliferative Disorder, FISH, Bone Marrow is requested.  

 

If follow-up testing is ordered within 12 months of a complete and informative PCPDS / Plasma Cell Proliferative Disorder, FISH, Bone Marrow result, the testing will be canceled. If follow up testing is ordered within 12 months of an initial partial or insufficient study, the testing will proceed.

Necessary Information

1. Include patient's disease state (untreated, treated, monoclonal gammopathy of undetermined significance, stable).

2. Indicate if patient is on anti-CD38 therapy.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Specimen Type: Redirected bone marrow

Preferred: Yellow top (ACD)

Acceptable: Lavender top (EDTA) or green top (heparin)

Specimen Volume: 4 mL

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Other Fully clotted

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Bone Marrow Ambient (preferred) 72 hours
Refrigerated 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Risk stratification of patients with multiple myeloma, which can assist in determining treatment and management decisions

 

Risk stratification of patients with newly diagnosed multiple myeloma

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Based on the flow cytometric analysis and the presence of greater than or equal to 0.1% monotypic plasma cells, the pre-analysis cell sorting and fluorescence in situ hybridization (FISH) for plasma cell proliferative disorders will be performed at an additional charge.

 

This test is designed for diagnostic specimens. If a request for testing has been submitted within 12 months of a complete and informative plasma cell proliferative disorder FISH study, the current test request will be canceled.

 

For more information see Multiple Myeloma: Laboratory Screening.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Multiple myeloma is increasingly recognized as a disease characterized by marked cytogenetic, molecular, and proliferative heterogeneity. This heterogeneity is manifested clinically by varying degrees of disease aggressiveness. Multiple myeloma patients with more aggressive disease experience suboptimal responses to some therapeutic approaches; therefore, identifying these patients is critically important for selecting appropriate treatment options.

 

Mayo Algorithmic Approach for Stratification of Myeloma and Risk-Adapted Therapy (MSMRT) classifies patients into either standard or high-risk categories based on the results of 2 assays: plasma cell proliferation and FISH for specific multiple myeloma-associated abnormalities.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

PLASMA CELL CLONALITY:

Normal bone marrow

No monotypic clonal plasma cells detected

 

DNA INDEX:

Normal polytypic plasma cells

DNA index (G0/G1 cells): Diploid 0.95-1.05

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided. Patients are classified as high risk, or standard risk.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Mayo Algorithmic Approach for Stratification of Myeloma and Risk-Adapted Therapy (MSMRT) report is best used for newly diagnosed patients with multiple myeloma. It is designed for patients with multiple myeloma and may not be applicable for monoclonal gammopathy of uncertain significance, smoldering myeloma, or amyloidosis.

 

This stratification system is not meant to replace existing prognostic systems such as the International Staging System.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Rajkumar SV, Greipp PR: Prognostic factors in multiple myeloma. Hematol Oncol Clin North Am 1999 Dec;13(6):1295-1314

2. Garcia-Sanz R, Gonzalez-Fraile MI, Mateo G, et al: Proliferative activity of plasma cells is the most relevant prognostic factor in elderly multiple myeloma patients. Int J Cancer 2004 Dec 10;112(5):884-889

3. Orfao A, Garcia-Sanz R, Lopez-Berges MC, et al: A new method for the analysis of plasma cell DNA content in multiple myeloma samples using a CD38/propidium iodide double staining technique. Cytometry 1994 Dec 1;17(4):332-339

4. Morice WG, Hanson CA, Kumar S, et al: Novel multi-parameter flow cytometry sensitively detects phenotypically distinct plasma cell subsets in plasma cell proliferative disorders. Leukemia 2007 Sep;21(9):2043-2046

5. Gonsalves WI, Buadi FK, Ailawadhi S, et al. Utilization of hematopoietic stem cell transplantation for the treatment of multiple myeloma: a Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) consensus statement. Bone Marrow Transplant. 2019;54(3):353–367. doi:10.1038/s41409-018-0264-8

6. Kapoor P, Ansell SM, Fonseca R, et al. Diagnosis and Management of Waldenstrom Macroglobulinemia: Mayo Stratification of Macroglobulinemia and Risk-Adapted Therapy (mSMART) Guidelines 2016. JAMA Oncol. 2017 Sep 1;3(9):1257–1265. doi:10.1001/jamaoncol.2016.5763

7. Mikhael JR, Dingli D, Roy V, et al. Management of newly diagnosed symptomatic multiple myeloma: updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines 2013 [published correction appears in Mayo Clin Proc. 2013 Jul;88(7):777. Stewart, Keith [corrected to Stewart, A Keith]]. Mayo Clin Proc. 2013;88(4):360–376. doi:10.1016/j.mayocp.2013.01.019

8. Swerdlow S, Campo E, Harris NL, et al: WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC Press: Lyon. 2017

9. Kumar SK, Rajkumar SV: The multiple myelomas-current concepts in cytogenetic classification and therapy. Nat Rev Clin Oncol 2018;15(7):409-421 doi:10.1038/s41571-018-0018-y

10. Rajkumar SV, Landgren O, Mateos MV: Smoldering multiple myeloma. Blood 2015 May 14;125(20):3069-3075 doi:10.1182/blood-2014-09-568899

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Flow cytometric immunophenotyping of bone marrow is performed using the following antibodies; CD19, CD38, CD45, CD138, cytoplasmic kappa and lambda immunoglobulin, and DAPI. Plasma cell clonality is detected through demonstrating CD38 and CD138 positivity along with immunoglobulin light chain restriction (ie, the presence of either predominately kappa or predominately lambda light chains) and abnormality of CD19 and/or CD45 expression. DNA index of clonal plasma cells and their proliferation activity is determined through staining of double-stranded DNA using DAPI.

 

Plasma cells (monoclonal/monotypic and polyclonal/polytypic) are detected by immunoglobulin light chain restriction, surface immunophenotype, and DNA content. If present, the light chain expressed by the monotypic plasma cells is indicated. The percentage of clonal plasma cells estimated by flow cytometry is affected by specimen processing and antigen loss with specimen aging. Manual differential counting remains the accepted standard for determining the bone marrow plasma cell percentage. The percentage of monotypic plasma cells in S-phase of the cell cycle is determined by quantitative DNA analysis. The DNA index is a calculated value. The presence of more than 1 value indicates the presence of cell populations with differing DNA contents within the monotypic plasma cells.(Dispenzieri A, Buadi F, Kumar SK, et al. Treatment of Immunoglobulin Light Chain Amyloidosis: Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) Consensus Statement. Mayo Clin Proc. 2015;90(8):1054–1081. doi:10.1016/j.mayocp.2015.06.009)

 

Plasma Cell Proliferative Disorder (PCPD):

This test is performed using both commercially available and laboratory developed probes. Deletion or monosomy of chromosomes 13 and 17 and copy number gain of 1q are detected using enumeration strategy probes. Centromere probes are used to detect chromosomal gain of chromosomes 3, 7, 9, and 15. Translocations involving IGH with FGFR3, CCND1, CCND3, MAF, and MAFB are detected using dual-color, dual-fusion (D-FISH) strategy probes. Rearrangement of IGH and MYC are detected using a break-apart strategy (BAP) probe. For each probe set, 50 plasma cells (if possible) are scored and the result for each probe is reported.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 11 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88182-Flow cytometry, cell cycle or DNA analysis

88184-Flow cytometry; first cell surface, cytoplasmic or nuclear marker

88185 x 5-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each)

88187-Flow cytometry interpretation, 2 to 8 Markers

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
MSMRT mSMART Algorithmic Testing, BM 93357-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CK056 Monotypic Plasma Cells: 93362-2
CK057 Monotypic PC per Total Events 93021-4
CK058 Monotypic Plasma Cells S-phase 93361-4
CK059 Monotypic Plasma Cells DNA Index 93360-6
CK060 Monotypic Plasma Cells DNA Ploidy 93359-8
CK061 Polytypic PC per Total Events 93358-0
CK062 Polytypic PC per All Plasma Cells 93020-6
CK134 Final Diagnosis 22637-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports