Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Phase 2

Completed

• Conditions: Primary Plasma Cell Leukemia

• Registration Number: NCT01553357
• Lead Sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-03
• Study First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Study First Posted: 2012-03-14
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate	4 months	IMWG criteria
Complete remission rate	4 months	IMWG
At least Very good partial remission rate	4 months	IMWG

Secondary Outcome Measures

Name	Time	Method
Progression free survival	24 months	Median follow-up
Overall survival	24 months	Median follow-up
Percentage of patients able to perform stem cell transplantation	12 months	Number of eligible patients reaching stem cell transplantation procedure
Safety	4-8 months, according to protocol	Number of severe/serious adverse events

Trial Locations

Locations (1)

IRCCS - CROB Ethic Committee; 🇮🇹 Rionero in Vulture, Pz, Italy