Test ID: SMART
Mayo Stratification for Myeloma and Risk-Adapted Therapy Report
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| MBM | Chromosomes, mSMART Eval, Marrow | No | Yes |
| FPCPD | Plasma Cell Prolif Disorder, FISH | Yes | Yes |
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| PCPRO | Plasma Cell Proliferation, Marrow | Yes | Yes |
| 88465 | Flow Cytometry Interp, 2-8 Markers | No | Yes |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When this test is ordered, Plasma Cell Proliferation, Marrow will always be performed at additional charge.
See Laboratory Screening Tests for Suspected Multiple Myeloma in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
MBM/27066: Includes 2 banded karyograms, analysis of 20 or more metaphases, and other techniques when required.
FPCPD/83358: Fluorescence In Situ Hybridization (FISH), Followed by Cytoplasmic Immunoglobulin (cIg) Staining
PCPRO/61654: Flow Cytometry, DNA Cell Cycle Analysis
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Deletion 13
Deletion 17p
Labeling Index
MGUS (monoclonal Gammopathy of Unknown Significance
Monoclonal Gammopathy of Unknown Significance (MGUS)
Monosomy 13
Multiple Myeloma
Myeloma Screen
p53
PCLI (Plasma Cell Labeling Index)
PCPD (Plasma Cell Proliferative Disorder)
Plasma Cell Labeling Index (PCLI)
Plasma Cell Leukemia
Rb1
t(11:14)
Translocation 11:14
TP53
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Provide a reason for referral and include disease state (untreated, treated, monoclonal gammopathy of undetermined significance, stable) with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed.
PCPRO
Specimen Type: Redirected bone marrow
Preferred: Yellow top (ACD solution B)
Acceptable: EDTA, heparin
Specimen Volume: 4 mL
Chromosome Analysis and PCPD FISH Testing
Specimen Type: Redirected bone marrow
Container/Tube: Green top (sodium heparin)
Specimen Volume: 2 mL
Additional Information: Other anticoagulants are not recommended and are harmful to the viability of the cells.
Forms: If not ordering electronically, submit a Cytogenetics Hematologic Disorders Request Form (Supply T607) with the specimen.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
Note: No specimen should be rejected. If specimen not received at appropriate temperature or in wrong anticoagulant, include note to laboratory. If questions, contact laboratory.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Bone Marrow | Ambient (preferred) | |
| Refrigerated | ||
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.
The Mayo Stratification for Myeloma and Risk-Adapted Therapy (mSMART) algorithm classifies patients into either standard or high-risk categories based on the results of 3 assays: the plasma cell proliferation result, conventional chromosome analysis, 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.
PCPRO
Estimated S-phase of >1.5% associated with more aggressive disease
CHROMOSOMES, mSMART EVALUATION
46,XX or 46,XY. No apparent chromosome abnormality.
An interpretative report will be provided.
PLASMA CELL PROLIFRATIVE DISORDER (PCPD)
An interpretative report will be provided.
Interpretation Provides information to assist in interpretation of the test results
An interpretive report is 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
The Mayo Stratification for Myeloma and Risk-Adapted Therapy 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 Provides recommendations for further in-depth reading of a clinical nature
1. Kumar SK, Mikhael JR, Buadi FK, et al: Management of newly diagnosed symptomatic multiple myeloma: updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines. Mayo Clin Proc 2009 Dec;84(12):1095-1110
2. Rajkumar SV, Greipp PR: Prognostic factors in multiple myeloma. Hematology/oncology clinics of North America 1999 Dec;13(6):1295-1314
3. 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
4. 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
5. 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
6. Morice WG, Chen D, Kurtin PJ, et al: Novel immunophenotypic features of marrow lymphoplasmacytic lymphoma and correlation with Waldenstrom's macroglobulinemia. Mod Pathol 2009 Jun;22(6):807-816
Method Description Describes how the test is performed and provides a method-specific reference
Chromosomes, mSMART Evaluation, Bone Marrow:
A cell count is performed on the specimen to establish a plating volume. Based on the cell count, a corresponding volume of bone marrow is added to 2 culture flasks containing culture medium and incubated for 24 to 48 hours at 37 degrees C. In the harvest process, the cells are exposed to colcemid, and hypotonic solution and fixed with glacial acid and methanol. Metaphases cells are dropped onto microscope slides and are routinely stained by G-banding, but other staining methods are frequently employed as needed. Twenty metaphases are usually examined. However, if a clone is suspected, but not confirmed within 20 metaphases, 30 metaphases will be analyzed. Minimal evidence for the presence of an abnormal clone is defined as 2 or more metaphases with the same structural abnormality or chromosome gain (trisomy), or 3 or more metaphases lacking the same chromosome. All cells analyzed are captured using a computerized imaging system, and 1 or more karyograms from each clone are prepared to document the type of abnormality and to permit systematic interpretation of the anomalies.(Dewald GW, Allen JE, Strutzenberg DK, Pierre RV: A cytogenetic method for mailed-in bone marrow specimens for the study of hematologic disorders. Lab Med 1982;13:225-229)
Plasma Cell Proliferative Disorder (PCPD), FISH:
This test uses commercially available and laboratory-developed chromosome-specific fluorescent-labeled DNA probes for FISH. Bone marrow samples are processed to keep the cytoplasm of the leukocytes intact. At least 2 slides with 2 hybridization sites each are prepared using a cytospin centrifuge. Each probe set is hybridized to a separate hybridization site. Plasma cells are specifically detected by using immunoglobulin staining techniques with commercially available antibodies (cIg) for kappa and lambda. Deletions or monosomies of chromosomes 13 and 17 are detected using FISH enumeration strategies. Centromere probes are used to detect chromosomal aneusomies for chromosomes 3, 7, 9, and 15. Translocation involving chromosome 14 (IGH) with chromosomes 4 (FGFR3), 11 (CCND1), or 16 (MAF) are detected by D-FISH strategies. For each probe set, 50 plasma cells (if possible) are scored and the result for each probe is reported.(Shaughnessy J, Tian E, Sawyer J, et al: High incidence of chromosome 13 deletion in multiple myeloma detected by multiprobe interphase FISH. Blood 2000 Aug 15;96[4]:1505-1511)
Plasma Cell DNA Content and Proliferation, Bone Marrow:
Flow cytometryDay(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
Chromosomes, mSMART Evaluation, Bone Marrow
88237-Tissue culture for bone marrow
88264-Chromosome analysis, hematologic disorders
88291-Interpretation and report
Plasma Cell Proliferative Disorder (PCPD), FISH
88240-Cryopreservation, freezing and storage of cells
88271 x 12-DNA probe, each
88275 x 2-Interphase in situ hybridization
88291-Interpretation and report
Plasma Cell Proliferation, Marrow
88184-Flow cytometry; first cell surface, cytoplasmic or nuclear marker
88185-Flow cytometry; additional cell surface, cytoplasmic or nuclear marker (each)
88182-Flow cytometry, cell cycle or DNA analysis
88187-Flow Cytometry Interpretation, 2 to 8 Markers
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 22613 | Specimen | In Process |
| 50477 | Specimen | In Process |
| 50478 | Specimen ID | In Process |
| 22614 | Specimen ID | In Process |
| 22615 | Source | In Process |
| 50479 | Source | In Process |
| 50490 | Order Date | N/A |
| 22616 | Order Date | N/A |
| G_569 | Reason For Referral | 42349-1 |
| CG301 | Reason For Referral | 42349-1 |
| 50492 | Method | In Process |
| 22618 | Method | In Process |
| 22619 | Results | In Process |
| 50493 | Banding Methods | In Process |
| 50553 | Result | In Process |
| 22620 | Interpretation | In Process |
| 22621 | Amendment | In Process |
| 50495 | Interpretation | In Process |
| 50494 | MSMART Evaluation | In Process |
| 22622 | Consultant | In Process |
| 22623 | Report Date | N/A |
| 50496 | Amendment | In Process |
| 50497 | Reviewed By | In Process |
| 50498 | Release Date | N/A |
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