Status:
COMPLETED
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Amgen
Conditions:
Lymphoma
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 per...
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 Melph...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00794261
Start Date
September 1 2008
End Date
June 1 2010
Last Update
July 8 2010
Active Locations (11)
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1
CHU Angers
Angers, France, 49000
2
CHU Brest
Brest, France, 29609
3
Centre Leon Berard
Lyon, France, 69008
4
Hopital Edouard Herriot
Lyon, France, 69008