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.