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Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
NCT01553357Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2009
- Primary completion
- Aug 2011
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- lenalidomide
- Conditions
- plasma cell leukaemia (PCL)
01
Overview
Phase 2, open-label, single-arm trial of lenalidomide in plasma cell leukaemia (PCL). Primary endpoints: Overall Response Rate at 4 months, Complete Remission Rate at 4 months and 1 more. Started Mar 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Lenalidomide + Dexamethasone
Induction with Lenalidomide and Dexamethasone, followed by maintenance Lenalidomide or SCT
03
Who it enrols
Newly diagnosed PPCL patients >18 years with ECOG 0-2. Excludes severe cardiac, hepatic, or renal dysfunction (unless disease-related), active infections, and HIV.
04
Endpoints
Primary
Overall Response Rate
Complete Remission Rate
Very Good Partial Remission Rate
Secondary
Progression Free Survival
Overall Survival
Stem Cell Transplantation Rate
Stem Cell Mobilization Rate
Safety and Adverse Events
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