From the Guidelines
A comprehensive workup for Multiple Myeloma (MM) should include a complete blood count, comprehensive metabolic panel, serum protein electrophoresis with immunofixation, serum free light chain assay, 24-hour urine protein electrophoresis, beta-2 microglobulin, and lactate dehydrogenase, as well as imaging studies such as a skeletal survey or low-dose whole-body CT scan, and bone marrow biopsy with aspirate for cytogenetic analysis, including FISH testing for high-risk features like t(4;14), t(14;16), and deletion 17p, as recommended by the most recent guidelines 1.
The initial diagnostic workup for MM should include:
- A history and physical examination
- Baseline blood studies, including:
- Complete blood count (CBC) with differential and platelet counts
- Blood urea nitrogen (BUN)
- Serum creatinine and serum electrolytes
- Serum calcium
- Albumin
- Lactate dehydrogenase (LDH)
- Beta-2 microglobulin
- Urine analysis, including:
- 24-hour urine protein electrophoresis
- Urine immunofixation electrophoresis
- Serum analysis, including:
- Quantitative immunoglobulin levels (IgG, IgA, and IgM)
- Serum protein electrophoresis
- Serum immunofixation electrophoresis
- Serum free light chain (FLC) assay
- Imaging studies, including:
- Skeletal survey or low-dose whole-body CT scan to assess for bone lesions
- MRI of the spine and pelvis if there are neurological symptoms
- PET-CT to identify extramedullary disease
- Bone marrow biopsy with aspirate to determine plasma cell percentage and for cytogenetic analysis, including FISH testing for high-risk features 1.
The serum FLC assay is a valuable tool in the diagnosis and monitoring of MM, and has prognostic value in plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering myeloma, active myeloma, immunoglobulin light chain amyloidosis, and solitary plasmacytoma 1.
Cytogenetic analysis, including FISH testing, is essential to identify high-risk features, such as t(4;14), t(14;16), and deletion 17p, which can impact treatment decisions and prognosis 1.
Early detection of high-risk features allows for more aggressive treatment approaches, potentially including proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and consideration for autologous stem cell transplantation in eligible patients 1.
This comprehensive evaluation helps establish the diagnosis, determine disease stage using the Revised International Staging System (R-ISS), and guide treatment decisions, ultimately improving patient outcomes in terms of morbidity, mortality, and quality of life.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Diagnostic Workup for Multiple Myeloma
The diagnostic workup for multiple myeloma includes:
- Complete blood count with differential 2
- Serum chemistries 2
- Creatinine, lactate dehydrogenase, and beta2-microglobulin tests 2, 3
- Immunoglobulin studies 2, 3
- Skeletal survey 2
- Bone marrow evaluation 2, 4
- Measurement of hemoglobin, serum creatinine, serum calcium, and serum free light chain levels 3
- Serum protein electrophoresis with immunofixation 3, 5
- 24-hour urine protein electrophoresis 3, 5
- Full-body skeletal imaging with computed tomography, positron emission tomography, or magnetic resonance imaging 3
Laboratory Tests and Diagnostic Criteria
Laboratory tests and diagnostic criteria for multiple myeloma include:
- Increased numbers of immature, abnormal, or atypical plasma cells in the bone marrow 2
- Monoclonal protein in the serum or urine 2
- Characteristic bone lesions 2
- Major and minor criteria to confirm the diagnosis of multiple myeloma and determine the classification and staging of multiple myeloma 4
Staging and Prognosis
The Revised International Staging System combines data from serum biomarkers and malignant plasma cell genomic features to assess estimated progression-free survival and overall survival 3
- Approximately 28% of patients are classified as having Revised International Staging stage I multiple myeloma, with a median 5-year survival of 82% 3