Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.

Korábbi kezelés

• Previous antimyeloma treatment including bisphosphonates

Más betegség

• Second Primary Malignancy and/or auto-immune disease treated by immunosuppressive drugs.
• History of malignancy other than SMM within 3 years before inclusion
• POEMS syndrome

Laborértékek

• Evidence of end organ damage that can be attributed to the underlying SMM:
  • Hypercalcaemia: serum calcium >0.25 mmol/L (>10 mg/L) higher than the upper limit of normal or >2.75 mmol/L (>110 mg/L)
  • Renal insufficiency: creatinine clearance <40 mL/min or serum creatinine >177 μmol/L (>20 mg/L)
  • Anaemia: haemoglobin value of >2 g/dL below the lower limit of normal, or a haemoglobin value <10 g/dL
  • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or Positron Emission Tomography-Computed Tomography (PET-CT)
• Presence of one of the following biomarkers of malignancy:
  • Clonal bone marrow plasmocytosis ≥60%
  • Involved/uninvolved serum Free Light Chain (FLC) ratio ≥ 100 (The involved free light chain must be ≥100 mg/L)
  • Presence of one or more focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)

Egyéb

• Amyloidosis
• Contraindication to MRI
• Pregnancy
• Nursing mother
• Legally protected adults (under judicial protection, guardianship, or supervision)

• Age ≥ 18 years.
• SMM defined by IMWG 2014 criteria
  • Serum monoclonal protein (IgG or IgA) ≥30 g/L and/or urinary monoclonal protein ≥500 mg per 24 h and/or clonal bone marrow plasma cells 10-60%
  • Absence of myeloma defining events or amyloidosis
• Diagnosed less than 1 year before the inclusion
• Able and willing to give valid written informed consent. Patients must give written informed consent (IC) in accordance with institutional and local guidelines.