Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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)