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)
18 Years
70 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
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)
OBJECTIVES:
Primary
- 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).
Secondary
- 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
leukapheresis.
- 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
post-transplantation.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of symptomatic stage I or stage II-III multiple myeloma
- Newly diagnosed disease
- No amyloidosis
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors)
- Platelet count ≥ 50 x 10^9/L (without transfusion support within the past 7 days)
- Serum calcium < 14 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- Creatinine clearance ≥ 50 mL/min
- Fertile patients must use effective contraception
- Negative pregnancy test
- Willing and able to comply with protocol requirements
Exclusion criteria:
- Myocardial infarction within the past 6 months
- New York Heart Association class III or IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmia
- Acute ischemia or active conduction system abnormalities as evidenced by ECG
- Serious medical condition that could prolong hematological recovery or preclude
completion of or tolerance to protocol therapy
- Seropositive for HIV antibody
- Known hepatitis B surface antigen positivity OR active hepatitis C infection
- Active systemic infection requiring treatment
- Pregnant or nursing
- Poor psychiatric condition
PRIOR CONCURRENT THERAPY:
- No plasmapheresis within the past 4 weeks
- No major surgery within the past 4 weeks
- No anticancer therapy within the past 5 years, except treatment for basal cell
carcinoma of the skin or carcinoma in situ of the uterine cervix
- No other concurrent G-CSF growth factors
- No concurrent enrollment in another investigational clinical trial
- No concurrent investigational agent that would contraindicate the use of
pegfilgrastim as either a mobilization agent or a hematological recovery agent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of patients with engraftment after induction chemotherapy
Safety Issue:
No
Principal Investigator
Walter Feremans, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Universitaire Erasme
Authority:
Unspecified
Study ID:
CDR0000561733
NCT ID:
NCT00526734
Start Date:
February 2006
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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