drugset / Trial / NCT00794261

Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma

NCT00794261

Phase 2 Completed 150 enrolled Centre Leon Berard Amgen · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months. The number of patients required in this multicentric and prospective study is 150 (13 participating centers). This is a phase II, controlled, randomized, non comparative and open-label multicentric study.

Timeline

Start
2008-09
Primary completion
2010-01
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Comparator filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications