A Pilot Study of Lenalidomide and Dexamethasone in Patients With 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
IMWG criteria
4 months
No
Pellegrino Musto, MD
Principal Investigator
GIMEMA Multiple Myeloma Working Party
Italy: The Italian Medicines Agency
CROB0108/1 -- RV-PCL-PI-350
NCT01553357
March 2009
September 2011
Name | Location |
---|