Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
PALM
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
2 other identifiers
interventional
150
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Sep 2008
Shorter than P25 for phase_2 lymphoma
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 8, 2010
July 1, 2010
1.3 years
November 19, 2008
July 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia
100 days
Secondary Outcomes (6)
Average duration of neutropenia, average duration of thrombocytopenia, number of days with temperature, number of red blood cell units and platelet concentrates transfused to the patient
100 days
Average duration of hospital stay since PSC transplantation
100 days
Number of bacterial and/or viral and/or fungal infections, average duration of antibiotic, antiviral and/or antifungal treatment
100 days
Treatment tolerance
100 days
Evaluation of treatment by Filgrastim
100 days
- +1 more secondary outcomes
Study Arms (2)
Pegfilgrastim
EXPERIMENTALSingle subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
Filgrastim
ACTIVE COMPARATORDaily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)
Interventions
Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)
Eligibility Criteria
You may qualify if:
- Male or female patients aged ≥ 18 years
- Patients with histologically confirmed lymphoma or myeloma
- 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.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Leon Berardlead
- Amgencollaborator
Study Sites (11)
CHU Angers
Angers, 49000, France
CHU Brest
Brest, 29609, France
Centre Leon Berard
Lyon, 69008, France
Hopital Edouard Herriot
Lyon, 69008, France
Hôpital Lapeyronnie
Montpellier, 34295, France
CHU Nantes
Nantes, 44000, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Henri Becquerel
Rouen, 76038, France
CHU Toulouse - Hôpital Purpam
Toulouse, 31000, France
CHU Tours - Hôpital Bretonneau
Tours, 37000, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine SEBBAN, MD
Centre Léon Bérard, Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 20, 2008
Study Start
September 1, 2008
Primary Completion
January 1, 2010
Study Completion
June 1, 2010
Last Updated
July 8, 2010
Record last verified: 2010-07