Carfilzomib studie

Behandelschema patiënt Carthadex 45 mg

Behandelschema patiënt Carthadex 56 mg

NB: doseringen afhankelijk van cohort.

Inclusion Criteria

  • Patients with a confirmed diagnosis of multiple myeloma stage I to III according to the ISS criteria (see appendix I);
  • Age 18-65 years inclusive;
  • WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) (see appendix II);
  • Negative urine pregnancy test at inclusion if applicable;
  • Written informed consent.

Exclusion Criteria

  • Known intolerance of Thalidomide;
  • Systemic AL amyloidosis;
  • Waldenstrom’s macroglobulinemia or IgM MM;
  • Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;
  • Severe cardiac dysfunction (NYHA classification II-IV, see appendix III);
  • Severe pulmonary dysfunction;
  • Significant hepatic dysfunction (serum bilirubin ≥ 30 μmol/l or transaminases ≥ 3.0 times normal level), unless related to myeloma;
  • Creatinine clearance <15 cc/min;
  • Alkaline Phosphatase >3x ULN;
  • ANC < 1,0 x109/L, platelets < 75 x109/L, Hb < 4.9 mmol/L;
  • Intolerance to thromboprophylaxis;
  • Patients known to be HIV-positive;
  • Patients with active, uncontrolled infections;
  • Patients with neuropathy, CTC grade 3 or higher or grade 2 painful peripheral neuropathy;
  • Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
  • Patients (all males and all pre-menopausal women) who are not willing or capable to use adequate contraception during the therapy;
  • Lactating women;
  • WHO Performance status > 3.