Clinical trial NCT00794261: Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Myeloma
Keywords: Myeloma
lymphoma
high-dose chemotherapy
PSC infusion, autologous
neutropenia
thrombocytopenia
hospital stay
infection
Autologous PSC transplantation for patients with lymphoma or myeloma treated with high-dose chemotherapy
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia
timeFrame: 100 days
Secondary outcomes:
measure: 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
timeFrame: 100 days
measure: Average duration of hospital stay since PSC transplantation
timeFrame: 100 days
measure: Number of bacterial and/or viral and/or fungal infections, average duration of antibiotic, antiviral and/or antifungal treatment
timeFrame: 100 days
measure: Treatment tolerance
timeFrame: 100 days
measure: Evaluation of treatment by Filgrastim
timeFrame: 100 days
measure: Evaluation of treatment costs in the two arms
timeFrame: 100 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Montpellier
country: France
facility: Hôpital Lapeyronnie
city: Nantes
country: France
facility: CHU Nantes
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Purpam
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Léon Bérard, LYON
name: Catherine SEBBAN, MD
role: PRINCIPAL_INVESTIGATOR
References: