Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
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ClinicalTrials.gov Identifier: NCT01553357
: March 14, 2012
Last Update Posted
: March 14, 2012
IRCCS Centro di Riferimento Oncologico della Basilicata
Information provided by (Responsible Party):
Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata
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).
Condition or disease
Primary Plasma Cell Leukemia
Drug: Lenalidomide, dexamethasone
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.
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
Age > 18 years
ECOG performance status of 0,1 or 2
Life expectancy of at least 12 weeks
Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
Severe uncontrolled ventricular arrhythmias
ECG evidence of acute ischemia or active conduction system abnormalities
Female subjects either pregnant or breast-feeding
Serious medical or psychiatric illness
Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)
History of severe hepatic dysfunction
Active infections or HIV positivity
Uncontrolled insulin-dependent diabetes mellitus
Uncompensated major thyroid or adrenal dysfunction
Hemodialysis or peritoneal dialysis
Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)