Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia

This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).

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)