Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia|
- Overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]IMWG criteria
- Complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]IMWG
- At least Very good partial remission rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]IMWG
- Progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]Median follow-up
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]Median follow-up
- Percentage of patients able to perform stem cell transplantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of eligible patients reaching stem cell transplantation procedure
- Safety [ Time Frame: 4-8 months, according to protocol ] [ Designated as safety issue: Yes ]Number of severe/serious adverse events
|Study Start Date:||March 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Drug: Lenalidomide, dexamethasone
Enrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle.
Patients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study.
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.
|IRCCS - CROB Ethic Committee|
|Rionero in Vulture, Pz, Italy, 85028|
|Principal Investigator:||Pellegrino Musto, MD||GIMEMA Multiple Myeloma Working Party|