Treatment With AMD3100 (Plerixafor) 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 of plerixafor and other outcomes that are purely exploratory
      in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between
      dosing with plerixafor and the beginning of apheresis to determine if there will be at least
      a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the
      determination of the dosing schedule for future studies.
    

Detailed description: 
      Participants with non-Hodgkin's lymphoma and multiple myeloma who have undergone prior
      cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a
      combination of plerixafor and granulocyte colony-stimulating factor (G-CSF) mobilization
      regimen on the day prior to apheresis. The only change to standard of European care is the
      addition of plerixafor to a G-CSF mobilizing regimen. Participants will undergo mobilization
      with G-CSF (10 µg/kg each day) and on each day prior to apheresis will receive plerixafor
      (240 µg/kg). Participants will undergo apheresis for up to 5 consecutive days in order to
      collect the target number of (≥ 5*10^6) CD34+ stem cells/kg. Participants will be
      transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The
      number of CD34+ cells mobilized in the peripheral blood from the time of the plerixafor dose
      to just prior to apheresis and those harvested in the apheresis product will be measured. The
      number of apheresis sessions required to obtain ≥ 5*10^6 CD34+ cells/kg will also be
      measured. Success of the transplantation(s) will be evaluated by the time to engraftment of
      poly-morphonuclear 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): Mozobil; AMD3100
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