A Randomised, International, Open-Label, Phase II Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization and Engraftment With Pegfilgrastim or Filgrastim for Autologous Transplantation in Patients With Multiple Myeloma (MM)
- Compare engraftment of peripheral blood progenitor cells (PBPCs) mobilized by 2
different fixed doses of pegfilgrastim versus a by-weight dose of filgrastim (G-CSF).
- Determine the ability of 2 different fixed doses of pegfilgrastim to mobilize PBPCs.
- Determine the safety of pegfilgrastim during PBPC mobilization and collection.
- Determine the effect of different induction chemotherapy regimens on autologous
progenitor cell transplantation.
OUTLINE: This is a multicenter study. Patients are stratified by type of induction
chemotherapy (Thal/Dex vs VAD vs Vel-Dex vs VTD) and by stage of disease according to
International Prognostic Index criteria (stage I [i.e., beta-2 microglobulin < 3.5 and
albumin > 35] vs stages II and III).
- Induction therapy: Patients receive 3-4 courses of 1 of the following regimens:
- VAD: Patients receive vincristine, doxorubicin hydrochloride, and dexamethasone.
- Thal/Dex: Patients receive thalidomide and dexamethasone.
- Vel-Dex: Patients receive bortezomib and dexamethasone.
- VTD: Patients receive bortezomib, thalidomide, and dexamethasone. Patients
achieving complete, partial, or minimal response after 3-4 courses of induction
therapy proceed to peripheral blood progenitor cell (PBPC) mobilization 17 days
after completion of induction therapy.
- PBPC mobilization: Patients are randomized to 1 of 3 arms.
- Arm I: Patients receive filgrastim subcutaneously (SC) once daily until the final
- Arm II: Patients receive a single dose of pegfilgrastim SC.
- Arm III: Patients receive pegfilgrastim as in arm II at a higher dose.
- Leukapheresis: Patients undergo up to 3 leukaphereses to obtain adequate numbers of
CD34-positive filgrastim- or pegfilgrastim-mobilized PBPCs for engraftment. Patients
achieving a sufficient number of collected PBSCs proceed to conditioning chemotherapy.
- Conditioning chemotherapy: Patients receive high-dose melphalan* IV over 1-2 days.
Patients then proceed to PBPC transplantation.
NOTE: *Patients ≥ 65 years old receive melphalan at a lower dose.
- Autologous PBPC transplantation: Patients undergo infusion of PBPCs on day 0. Patients
in all arms receive G-CSF support beginning on day 1 after PBPC transplantation and
continuing until blood counts recover for 3 consecutive days.
After completion of study therapy, patients are followed for up to 100 days
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Number of patients with engraftment after induction chemotherapy
Walter Feremans, MD, PhD
Hopital Universitaire Erasme