Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
Condition: Lymphoma, Non-Hodgkin; Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and efficacy of plerixafor given in addition to
      granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells
      (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and
      multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating
      CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor
      (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN)
      engraftment after transplantation. Data from this protocol will assist in the determination
      of the dosing schedule for future studies.
    

Detailed description: 
      Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be
      autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter
      the study. The only change to the standard of care is the addition of plerixafor to a
      granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to
      apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will
      receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo
      apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem
      cells (≥ 5*10^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all
      participants will be treated with high-dose chemotherapy in preparation for transplantation.
      Participants will be transplanted with cells obtained from the G-CSF and plerixafor
      mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of
      the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the apheresis
      product will be measured. The number of apheresis sessions required to obtain ≥ 5*10^6 CD34+
      cells will also be measured. Success of the transplantation(s) will be evaluated by the time
      to engraftment of polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will
      be followed for durability of their transplant for 12 months following transplantation.

      This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
      acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
    

Intervention name(s): G-CSF Plus Plerixafor
Intervention type(s): Drug
Intervention description(s): Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Other intervention name(s): AMD3100; Mozobil
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin's Lymphoma; Multiple Myeloma; Stem cell mobilization