Clinical trial NCT01553357: Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
Official title: A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Plasma Cell Leukemia
Keywords: Plasma cell leukemia
Lenalidomide
Dexamethasone
Multiple myeloma
Bortezomib
Stem cell transplantation
Lead sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2012-03-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Overall response rate
timeFrame: 4 months
measure: Complete remission rate
timeFrame: 4 months
measure: At least Very good partial remission rate
timeFrame: 4 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Percentage of patients able to perform stem cell transplantation
timeFrame: 12 months
measure: Safety
timeFrame: 4-8 months, according to protocol
Other outcomes:
Locations:
city: Rionero in Vulture
country: Italy
facility: IRCCS - CROB Ethic Committee
state: Pz
Study officials:
affiliation: GIMEMA Multiple Myeloma Working Party
name: Pellegrino Musto, MD
role: PRINCIPAL_INVESTIGATOR
References: