Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma

Lymphoma Clinical Trial

— PALM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794261
• Other study ID #: PALM
• Secondary ID: ET2007 - 113
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2008
• Last updated: July 7, 2010
• Start date: September 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	Amgen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia		100 days	No
Secondary	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	No
Secondary	Average duration of hospital stay since PSC transplantation		100 days	No
Secondary	Number of bacterial and/or viral and/or fungal infections, average duration of antibiotic, antiviral and/or antifungal treatment		100 days	No
Secondary	Treatment tolerance		100 days	No
Secondary	Evaluation of treatment by Filgrastim		100 days	No
Secondary	Evaluation of treatment costs in the two arms		100 days	No