Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma

NCT ID: NCT00794261

Last Updated: 2010-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegfilgrastim

Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5

Group Type: EXPERIMENTAL

Injection of Pegfilgrastim

Intervention Type: DRUG

Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5

Filgrastim

Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)

Group Type: ACTIVE_COMPARATOR

Injection of Filgrastim

Intervention Type: DRUG

Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)

Interventions

Injection of Pegfilgrastim

Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged ≥ 18 years
• Patients with histologically confirmed lymphoma or myeloma
• Treatment with high-dose chemotherapy before inclusion

• Intensification with high dose Melphalan for patients with myeloma
• Whatever the conditioning regimen, except TBI for patients with 1st relapse of Hodgkin's lymphoma or with MNHL NB: Patients having received two intensification courses are eligible if there has been more than 100 days between courses.
• Autologous PSC transplantation at the time of inclusion
• Reinjection of ≥ 2.106 CD34/kg
• Patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (PNN > 0.5 G/L)
• Mandatory affiliation with a health insurance system
• Patients able to understand, read and write French
• Signed, written informed consent

Exclusion Criteria

• TBI during conditioning
• Severe intolerance to the growth factor under study, or hypersensitivity to one of their components
• Immunosuppressive syndrome
• Pregnant or lactating women
• Difficult follow-up
• Documented history of cognitive or psychiatric disorders
• Participation or consideration of participation in another biomedical study during the follow-up period of the present trial.

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

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE

Principal Investigators

Catherine SEBBAN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, Lyon

Locations

CHU Angers

Angers, , France

CHU Brest

Brest, , France

Centre Leon Berard

Lyon, , France

Hopital Edouard Herriot

Lyon, , France

Hôpital Lapeyronnie

Montpellier, , France

CHU Nantes

Nantes, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Centre Henri Becquerel

Rouen, , France

CHU Toulouse - Hôpital Purpam

Toulouse, , France

CHU Tours - Hôpital Bretonneau

Tours, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

ET2007 - 113

Identifier Type: -

Identifier Source: secondary_id

PALM

Identifier Type: -

Identifier Source: org_study_id