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HOVON 104

Inclusion criteria

  • Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy,
  • Age 18 -70 years inclusive at the time of signing the informed consent form,
  • Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC > 50 mg/L,
  • Life expectancy > 3 months,
  • WHO performance status 0-2,
  • NYHA stage 1-2,
  • Negative pregnancy test at inclusion for women of childbearing potential,
  • Written informed consent.

Exclusion criteria

  • Multiple Myeloma stage II and III (Durie and Salmon),
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
  • Previous treatment for plasma cell dyscrasia,
  • Pregnant or breast feeding females,
  • Presence of other active malignancy or a history of active malignancy during the past 5 years, with the exception of nonmelanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits,
  • Hypersensitivity to boron or mannitol,
  • Uncontrolled infection,
  • Symptomatic orthostatic hypotension defined as a decrease in systolic blood pressure on standing of >20 mmHg combined with symptoms like dizziness, cerebral and/or cardial ischemia,
  • Symptomatic effusions, defined as pleural effusion or ascites needing drainage therapy,
  • Positive for HIV or infectious hepatitis, B or C (screening obligatory),
  • Bilirubin > 2x upper limit of normal,
  • Creatinine clearance < 30 ml/min (after rehydration),
  • Absolute neutrophil count < 1.0 × 109/L,
  • NCI CTCAE grade peripheral sensory neuropathy > grade 2,
  • NCI CTCAE grade peripheral sensory neuropathy > grade 1 in the presence of neuropathic pain,
  • Concurrent diagnosis of B-cell NHL or B-CLL,
  • Previous organ transplantation,
  • Unwilling or unable to use adequate contraception

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