Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

NCT ID: NCT01553357

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-09-30

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.

Conditions

Primary Plasma Cell Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Revlimid

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

IRCCS Centro di Riferimento Oncologico della Basilicata

OTHER

Sponsor Role: lead

Responsible Party

Pellegrino Musto

Onco-Hematology Department Director at IRCCS-CROB Rionero in Vulture, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pellegrino Musto, MD

Role: PRINCIPAL_INVESTIGATOR

GIMEMA Multiple Myeloma Working Party

Locations

IRCCS - CROB Ethic Committee

Rionero in Vulture, Pz, Italy

Countries

Italy

Other Identifiers

2008-003246-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

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

Identifier Type: -

Identifier Source: org_study_id