What are the diagnostic criteria for multiple myeloma (Plasma Cell Myeloma)?

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Last updated: May 9, 2025View editorial policy

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From the Guidelines

Multiple myeloma diagnosis requires a combination of blood tests, urine tests, bone marrow biopsy, and imaging studies, with diagnostic criteria including evidence of clonal bone marrow plasma cells ≥10% or biopsy-proven plasmacytoma, plus at least one myeloma-defining event, as outlined in the International Myeloma Working Group (IMWG) diagnostic criteria 1. The diagnostic workup for multiple myeloma should include:

  • Initial testing with complete blood count, comprehensive metabolic panel, serum protein electrophoresis with immunofixation, serum free light chain assay, 24-hour urine protein electrophoresis, and bone marrow aspiration and biopsy
  • Advanced imaging such as whole-body low-dose CT, PET/CT, or MRI to detect bone lesions
  • Cytogenetic testing of bone marrow plasma cells to determine prognosis, with high-risk features including del(17p), t(4;14), t(14;16), and t(14;20) 1 Key considerations in the diagnosis of multiple myeloma include:
  • The presence of end-organ damage, such as hypercalcemia, renal insufficiency, anemia, or bone lesions, which is a key component of the CRAB criteria 1
  • The use of serum free light chain assay to monitor disease response and progression, particularly in patients with nonsecretory myeloma 1
  • The importance of early diagnosis, as treatment outcomes are better when initiated before significant end-organ damage occurs, and modern therapies have significantly improved survival rates for multiple myeloma patients 1

From the Research

Multiple Myeloma Diagnosis

  • Multiple myeloma is a hematologic malignancy characterized by the presence of abnormal clonal plasma cells in the bone marrow, with potential for uncontrolled growth causing destructive bone lesions, kidney injury, anemia, and hypercalcemia 2.
  • The diagnosis of multiple myeloma involves the evaluation of patients with possible multiple myeloma, including measurement of hemoglobin, serum creatinine, serum calcium, and serum free light chain levels; serum protein electrophoresis with immunofixation; 24-hour urine protein electrophoresis; and full-body skeletal imaging with computed tomography, positron emission tomography, or magnetic resonance imaging 2.
  • Serum protein electrophoresis (SPEP) is an easy-to-perform laboratory test that can be used for detection and quantification of monoclonal gammopathy and should be recommended as a preliminary test for suspected cases of multiple myeloma 3.
  • Immunofixation electrophoresis detection technique can be used for screening M protein in patients with atypical multiple myeloma, and can increase the diagnosis accuracy in patients with atypical multiple myeloma 4.

Diagnostic Techniques

  • Serum protein electrophoresis is used to identify patients with multiple myeloma and other serum protein disorders, and can help differentiate multiple myeloma from other causes of monoclonal gammopathy 5.
  • Urine immunofixation is not always necessary for defining complete response in multiple myeloma patients, other than those with light-chain-only disease 6.
  • The detection rate of M protein by immunofixation electrophoresis detection is better than that of serum protein electrophoresis, and can be used to detect M protein in patients with atypical multiple myeloma 4.

Diagnosis and Staging

  • 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 2.
  • At diagnosis, 28% of patients are classified as having Revised International Staging stage I multiple myeloma, and these patients have a median 5-year survival of 82% 2.
  • Approximately 34,920 people in the US and 155,688 people worldwide are diagnosed with multiple myeloma each year, with an estimated 73% having anemia, 79% having osteolytic bone disease, and 19% having acute kidney injury at the time of presentation 2.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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