A Phase 2 interventional study of Lenalidomide, dexamethasone in Primary Plasma Cell Leukemia, sponsored by IRCCS Centro di Riferimento Oncologico della Basilicata. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-14.
Sponsored by IRCCS Centro di Riferimento Oncologico della Basilicata · Phase 2, Interventional, and Treatment
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).
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 23 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →IRCCS Centro di Riferimento Oncologico della Basilicata is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Revlimid
Overall response rate
IMWG criteria
Time frame: 4 months
Complete remission rate
IMWG
Time frame: 4 months
At least Very good partial remission rate
IMWG
Time frame: 4 months
Progression free survival
Median follow-up
Time frame: 24 months
Overall survival
Median follow-up
Time frame: 24 months
Percentage of patients able to perform stem cell transplantation
Number of eligible patients reaching stem cell transplantation procedure
Time frame: 12 months
Safety
Number of severe/serious adverse events
Time frame: 4-8 months, according to protocol
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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IRCCS Centro di Riferimento Oncologico della Basilicata