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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

Phase 2
18 Years
Not Enrolling
Lymphoma, Myeloma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

Catherine SEBBAN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, LYON


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2008

Completion Date:

June 2010

Related Keywords:

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