Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.

Inclusion criteria

• Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
• Age > 18 years
• ECOG performance status of 0,1 or 2
• Life expectancy of at least 12 weeks

Exclusion criteria

• Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
• Severe uncontrolled ventricular arrhythmias
• ECG evidence of acute ischemia or active conduction system abnormalities
• Female subjects either pregnant or breast-feeding
• Serious medical or psychiatric illness
• Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)
• History of severe hepatic dysfunction
• Active infections or HIV positivity
• Uncontrolled insulin-dependent diabetes mellitus
• Uncompensated major thyroid or adrenal dysfunction
• Hemodialysis or peritoneal dialysis
• Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
• ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)