NCT00794261

Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma

Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

High-dose chemotherapy with autologous peripheral stem cell (PSC) transplantation is a standard consolidation treatment for the initial management of patients with myeloma treated with high-dose Melphalan, or patients with certain lymphomas or with chemosensitive relapses of Hodgkin's lymphoma (HL) or malignant non Hodgkin's lymphoma (MNHL). This procedure is associated with prolonged neutropenia and considerable morbidity. Many randomized trials have tested post-graft administration of granulocyte growth factors (granulocyte colony stimulating Factor: G-CSF) or granulocyte-monocyte growth factors (granulocyte macrophage colony stimulating Factor: GM-CSF). All have shown a reduction of neutropenia and shorter hospital stays on G-CSF or GM-CSF treatment. Different guidelines have recommended the use of growth factors after autologous stem cell transplantation. The effectiveness of growth factor treatment would be identical, whether given immediately after PSC transplantation or delayed until D5 or D7. Pegfilgrastim is a growth factor resulting from the modification of Filgrastim by addition of a polyethylene glycol (PEG) moiety, which increases its half-life by decreasing its renal clearance. Thus, one injection is equivalent to several Filgrastim injections. Studies of Pegfilgrastim or Filgrastim efficacy on the duration of chemotherapy-induced neutropenia in patients with breast cancer or with non-small cell lung cancer or LMNH have produced equivalent results. In haematology, Pegfilgrastim has been used for PSC mobilization. Six studies evaluating the efficacy of Pegfilgrastim compared to other G-CSF after autologous hematopoietic PSC transplantation in patients with myeloma and lymphomas have shown equivalent results. A superiority of Pegfilgrastim over other G-CSF has even been reported (though in only one randomized small-scale study). A randomized phase II study evaluating Pegfilgrastim efficacy and tolerance in lymphoma or myeloma patients receiving PSC transplantation appears necessary to confirm or refute the potential clinical interest of the drug. On the day of autologous PSC transplantation (D0) the patients will be randomly assigned to receive one or the other treatment strategy. NB: Patients will receive support care, antibiotic treatments and transfusion procedures specific to each participating centre. They will be followed-up according to recommendations for the management of this type of patients. No additional examination is planned.

Conditions

• Lymphoma
• Myeloma

Interventions

Type	Name	Description
DRUG	Injection of Pegfilgrastim	Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
DRUG	Injection of Filgrastim	Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-01-01
• Completion: 2010-06-01
• First posted: 2008-11-20
• Last updated: 2010-07-08

Locations

11 sites across 1 country: France