Originele protocol


Inclusion criteria

  • Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A)
  • Age ≥ 75 years
  • WHO performance status 0-3, WHO 4 performance status is allowed when related to MM (see appendix E)
  • Measurable disease as defined by the presence of M-protein in serum or urine and/or abnormal free light chain (FLC) ratio with involved FLC (see appendix A for definitions)
  • Written informed consent

Exclusion criteria

  • Non-secretory MM
  • Systemic Amyloid Light-chain (AL) amyloidosis
  • Polyneuropathy, grade 1 with pain or grade ≥ 2
  • Severe cardiac dysfunction (NYHA classification IV, appendix F)
  • Severe pulmonary dysfunction defined as breathlessness at rest
  • Significant hepatic dysfunction (total bilirubin ≥ 30 μmol/l or transaminases ≥ 3 times normal level), unless related to MM
  • Renal insufficiency requiring dialysis
  • Patients with active, uncontrolled infections
  • Pre-treatment with cytostatic drug, immunomodulatory drugs (IMiDs) or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed
  • Patients known to be Human Immunodeficiency Virus (HIV)-positive
  • Active malignancy other than MM requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule