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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)

Phase 2
18 Years
70 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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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)



- 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

Inclusion Criteria


- Diagnosis of symptomatic stage I or stage II-III multiple myeloma

- Newly diagnosed disease

- No amyloidosis


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


- 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:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with engraftment after induction chemotherapy

Safety Issue:


Principal Investigator

Walter Feremans, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Universitaire Erasme



Study ID:




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