NCT01553357

Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: IRCCS Centro di Riferimento Oncologico della Basilicata · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2012-03-14
• Last updated: 2012-03-14

Locations

1 site across 1 country: Italy