Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Primary Plasma Cell Leukemia Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Plasma Cell
• Primary Plasma Cell Leukemia

• NCT number: NCT01553357
• Study type: Interventional
• Source: IRCCS Centro di Riferimento Oncologico della Basilicata
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Completion date: September 2011