Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Primary Plasma Cell Leukemia Clinical Trial

Official title:

A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553357
• Other study ID #: CROB0108/1 -- RV-PCL-PI-350
• Secondary ID: 2008-003246-28
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2012
• Last updated: March 13, 2012
• Start date: March 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2012
• Source: IRCCS Centro di Riferimento Oncologico della Basilicata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Plasma Cell
• Primary Plasma Cell Leukemia

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS - CROB Ethic Committee	Rionero in Vulture	Pz

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Centro di Riferimento Oncologico della Basilicata	Celgene Corporation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	IMWG criteria	4 months	No
Primary	Complete remission rate	IMWG	4 months	No
Primary	At least Very good partial remission rate	IMWG	4 months	No
Secondary	Progression free survival	Median follow-up	24 months	No
Secondary	Overall survival	Median follow-up	24 months	No
Secondary	Percentage of patients able to perform stem cell transplantation	Number of eligible patients reaching stem cell transplantation procedure	12 months	No
Secondary	Safety	Number of severe/serious adverse events	4-8 months, according to protocol	Yes