Clinical Trial: Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
Brief 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).
Detailed Summary: 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.
Sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata
Current Primary Outcome:
- Overall response rate [ Time Frame: 4 months ]IMWG criteria
- Complete remission rate [ Time Frame: 4 months ]IMWG
- At least Very good partial remission rate [ Time Frame: 4 months ]IMWG
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression free survival [ Time Frame: 24 months ]Median follow-up
- Overall survival [ Time Frame: 24 months ]Median follow-up
- Percentage of patients able to perform stem cell transplantation [ Time Frame: 12 months ]Number of eligible patients reaching stem cell transplantation procedure
- Safety [ Time Frame: 4-8 months, according to protocol ]Number of severe/serious adverse events
Original Secondary Outcome: Same as current
Information By: IRCCS Centro di Riferimento Oncologico della Basilicata
Dates:
Date Received: March 3, 2012
Date Started: March 2009
Date Completion:
Last Updated: March 13, 2012
Last Verified: March 2012