What are the diagnostic criteria and treatment options for multiple myeloma?

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Last updated: September 24, 2025View editorial policy

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Diagnosis and Treatment of Multiple Myeloma

The diagnosis of multiple myeloma requires ≥10% clonal bone marrow plasma cells or a biopsy-proven plasmacytoma plus evidence of end-organ damage (CRAB criteria) or specific biomarkers indicating disease severity. 1, 2

Diagnostic Criteria

Required Elements for Diagnosis

  • ≥10% clonal bone marrow plasma cells or biopsy-proven plasmacytoma
  • PLUS one or more of the following multiple myeloma defining events (MDE):
    • CRAB features attributable to the plasma cell disorder:
      • C: Hypercalcemia (serum calcium >11 mg/dL)
      • R: Renal insufficiency (creatinine >2 mg/dL or creatinine clearance <40 mL/min)
      • A: Anemia (hemoglobin <10 g/dL or >2 g/dL below normal)
      • B: Bone lesions (one or more osteolytic lesions on skeletal radiography, CT, or PET-CT)
    • OR one of the following biomarkers of malignancy:
      • Bone marrow clonal plasma cells ≥60%
      • Serum involved/uninvolved free light chain (FLC) ratio ≥100 (provided involved FLC is ≥100 mg/L)
      • 1 focal lesion on MRI (≥5 mm in size)

Essential Diagnostic Workup

  1. Laboratory Studies:

    • Complete blood count with differential
    • Serum chemistries including calcium, creatinine
    • Serum protein electrophoresis (SPEP) and immunofixation
    • Serum free light chain assay
    • 24-hour urine protein electrophoresis and immunofixation
    • Beta-2 microglobulin, albumin, and LDH (for staging)
  2. Bone Marrow Examination:

    • Bone marrow biopsy and aspiration (performed simultaneously)
    • Assessment of plasma cell percentage and morphology
    • Immunophenotyping by flow cytometry
    • FISH analysis for high-risk cytogenetic abnormalities
  3. Imaging:

    • Skeletal survey or low-dose whole-body CT
    • Consider MRI for suspected spinal cord compression or to detect focal lesions
    • PET-CT may be useful for disease assessment

Risk Stratification

International Staging System (ISS)

  • Stage I: Beta-2 microglobulin <3.5 mg/L and albumin ≥3.5 g/dL
  • Stage II: Not meeting criteria for Stage I or III
  • Stage III: Beta-2 microglobulin ≥5.5 mg/L

Cytogenetic Risk Classification

  • High-risk features: del(17p), t(4;14), t(14;16), t(14;20), gain 1q, del 1p, or p53 mutation
  • Double-hit myeloma: Presence of any two high-risk factors
  • Triple-hit myeloma: Three or more high-risk factors

Treatment Approach

Transplant-Eligible Patients

  1. Induction Therapy:

    • Standard risk: Bortezomib, lenalidomide, dexamethasone (VRd)
    • High risk: Consider daratumumab-VRd (Dara-VRd)
    • Typically 3-4 cycles before proceeding to transplant
  2. Autologous Stem Cell Transplantation (ASCT)

    • Standard of care for eligible patients
    • Selected standard-risk patients may delay transplant until first relapse
  3. Maintenance Therapy:

    • Standard risk: Lenalidomide maintenance
    • High risk: Bortezomib plus lenalidomide maintenance

Transplant-Ineligible Patients

  1. Primary Therapy:

    • VRd for approximately 8-12 cycles followed by maintenance
    • Alternative: Daratumumab, lenalidomide, dexamethasone (DRd) until progression 1, 3
  2. Maintenance Therapy:

    • Similar approach to transplant-eligible patients based on risk

Relapsed/Refractory Disease

  • Triplet regimens typically needed at relapse
  • Options include:
    • Carfilzomib-based regimens 4
    • Daratumumab-based combinations
    • Newer agents: CAR-T cell therapy and bispecific antibodies for later lines 2

Supportive Care

  • Thromboprophylaxis for patients on immunomodulatory drugs
  • Bisphosphonates for bone disease
  • Antimicrobial prophylaxis to prevent infections
  • Regular monitoring of M-protein levels to assess response
  • Assessment for treatment-related toxicities

Common Pitfalls and Caveats

  • Diagnostic confusion: Distinguish multiple myeloma from MGUS and smoldering multiple myeloma
  • Inadequate risk assessment: Failure to perform FISH analysis for high-risk cytogenetics
  • Delayed recognition: Nonspecific symptoms may lead to delayed diagnosis
  • Renal function monitoring: Critical to preserve renal function and adjust medication dosing
  • Hydration management: Adequate hydration is essential, especially during initial therapy, to prevent tumor lysis syndrome and renal toxicity 4

Multiple myeloma treatment should be initiated promptly after diagnosis, with referral to a hematologist/oncologist for specialized care and consideration of clinical trials when appropriate.

References

Guideline

Hematological Disorders

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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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