EMN15

Title

Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase 2 Study

Overview / Summary

Study details

Patient eligibility criteria

  • Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma based on the 2014 International Myeloma Working Group Criteria:
    • Serum M-protein ≥30 g/L, or urinary monoclonal protein >500 mg per 24 hours, and/or monoclonal bone marrow plasma cells ≥10-60 %
    • Absence of CRAB symptoms:- anemia: Hemoglobin <6.2 mmol/L (10 g/dl) or a hemoglobin value of >1.2 mmol/L (2 g/dL) below the lower limit of normal
      – renal failure: serum creatinine > 2.0 mg/dL or creatinine clearance < 40 ml/min
      – hypercalcemia: serum calcium >0·25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2·75 mmol/L (>11 mg/dL)
      – Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
    • Absence of myeloma defining events:
      – Involved/uninvolved serum free light chain ratio ≥100 with involved free light-chain concentration ≥10 mg/dl
      – Presence of 2 or more focal lesions by MRI (2 of which at least 5 mm)
      – Clonal bone marrow plasma cell percentage ≥60%
  • Patients must have high risk Smoldering Multiple Myeloma based on the Mayo Clinic or the PETHEMA criteria:
    • 3 factors of Mayo Clinic criteria:
      – Bone marrow plasma cells ≥10 %
      – Serum M-protein ≥ 3 g/dl
      – Serum free light-chain ratio <0.125 or >8
    • Or 2 factors of PETHEMA criteria:
      – ≥95% abnormal plasma cells including decreased CD38 expression, expression of CD56, and absence of CD19 and/or CD45
      – Immunoparesis, a reduction (below the lower normal limit) in the levels of 1 or 2 of the uninvolved immunoglobulins (Ig)
  • Measurable disease defined by any one of the following:
    • Serum monoclonal protein ≥ 1.0 g/dl
    • Urine monoclonal protein >200 mg/24 hour
    • Serum immunoglobulin free light chain >10 mg/dL AND abnormal kappa/lambda ratio (reference 0.26-1.65)

Publications

No publications connected to this trial at the moment