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Test Code MISC2MAYOMSMRT Mayo Algorithmic Approach for Stratification of Myeloma and Risk-Adapted Therapy Report, Bone Marrow

Secondary ID

64946

Useful For

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

 

Risk stratification of patients with newly diagnosed multiple myeloma

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
CSMRT MPCDS Pre-Analysis Cell Sorting, BM No No
MPCDS mSMART Eval, PCPDs, FISH Yes, (Order PCPDS) No

Testing Algorithm

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 for plasma cell proliferative disorders will be performed at an additional charge.

 

For more information see Multiple Myeloma: Laboratory Screening.

Method Name

Flow Cytometry/DNA Content/Cell Cycle Analysis

Reporting Name

mSMART Algorithmic Testing, BM

Specimen Type

Bone Marrow


Ordering Guidance


This test should be ordered at diagnosis or for a known relapsing patient of multiple myeloma and when MPCDS / mSMART, Plasma Cell Proliferative Disorder, FISH, Bone Marrow is requested.

 

For follow-up of a plasma cell neoplasm (plasma cell proliferative disorder), order MSMRD / Myeloma Stratification and Risk-Adapted Therapy with Reflex to Minimal Residual Disease, Bone Marrow.



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


Specimen Type: Redirected bone marrow

Preferred: Yellow top (ACD solution A or B

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

Specimen Volume: 4 mL


Specimen Minimum Volume

3 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Fully clotted Reject

Clinical Information

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 fluorescence in situ hybridization for specific multiple myeloma-associated abnormalities.

Reference Values

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

The interpretation of results includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.

Method Description

Flow cytometric immunophenotyping of bone marrow is performed using the following antibodies: CD19, CD38, CD45, CD138, cytoplasmic kappa and lambda immunoglobulin, and DAPI (4',6-diamidino-2-phenylindole). 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 lambda immunoglobulin 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:

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 probe. For each probe set, 50 plasma cells (if possible) are scored and the result for each probe is reported.(Unpublished Mayo method)

Day(s) Performed

Preanalytical processing: Monday through Saturday

Results reported: Monday through Friday

Report Available

1 to 11 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

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 Code Information

Test ID Test Order Name Order LOINC Value
MSMRT mSMART Algorithmic Testing, BM 93363-0

 

Result ID Test Result Name Result LOINC Value
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

Forms

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