Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

August 31, 2011

Study Completion Date

September 30, 2011

Conditions
Primary Plasma Cell Leukemia
Interventions
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."

Trial Locations (1)

85028

IRCCS - CROB Ethic Committee, Rionero in Vulture

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

IRCCS Centro di Riferimento Oncologico della Basilicata

OTHER