HOVON 129 (FL)

Carfilzomib and lenalidomide-based treatment for transplant eligible and non-transplant eligible newly diagnosed primary plasma cell leukemia patients

Inclusion criteria

• Patients with diagnosis of symptomatic pPCL
• Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein > 5 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma by biopsy)
• Age ≥18 years
• WHO-performance status 0-3 

Exclusion criteria

• Any current CNS involvement with disease refractory to intrathecal chemotherapy.
• Severe cardiac dysfunction (NYHA classification II-IV, see appendix E) - Myocardial infarction within 6 months, unstable angina, and cardiac arrhythmias which are not controlled by conventional treatment (including medications and cardiac devices)
• Severe pulmonary dysfunction
• Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3.0 times normal level), unless related to pPCL
• Patients with GFR < 15 ml/min

Participating sites

• ZNA Stuivenberg
• UZ Antwerpen
• Sint-Jan ziekenhuis Brugge
• CHU Liège