Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

IRCCS Centro di Riferimento Oncologico della Basilicata

Status and phase

Completed

Phase 2

Conditions

Primary Plasma Cell Leukemia

Treatments

Drug: Lenalidomide, dexamethasone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01553357

2008-003246-28 (EudraCT Number)

CROB0108/1 -- RV-PCL-PI-350

Details and patient eligibility

About

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).

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)