Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: Amgen
• Treatments: Lenograstim

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.