Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Condition: Multiple Myeloma; Non-Hodgkins Lymphoma; Hodgkins Disease
MeSH terms: Multiple Myeloma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte
      colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both
      healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via
      apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008,
      Plerixafor received approval from the Food and Drug administration for use in combination
      with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is
      not designed to support approval of a new indication or change in the advertising for
      Plerixafor. The route of administration and dosage level are identical to that which is
      listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins
      Lymphoma, there is no known or theoretic increased risk of the use of this drug in this
      patient population.

      The study hypothesis for this study is that patients with a circulating CD34+ count < 20
      cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X
      10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
    

Detailed description: 
      This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins
      lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation
      are eligible to enter into the study. The only change to the standard of care is the addition
      of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization.

      The results of the study will provide both numeric and categorical estimates of measurements
      of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success,
      is a binary response variable categorizing whether the patient was able to mobilize at least
      2 X 10(6) CD34+ cells/kg within 3 days of apheresis.

      The percentage of patients achieving Treatment Success will be summarized. All AEs will be
      followed for 30 days after the last apheresis or until the first dose of ablative
      chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant
      or until relapse. All patients who receive at least one dose of Plerixafor will be included
      in all summaries of AEs.
    

Intervention name(s): G-CSF plus Plerixafor
Intervention type(s): Drug
Intervention description(s): On Day 5 of G-CSF mobilization,
if the patient's peripheral CD34+ cell count is < 7cells/µl then 240ug/kg Plerixafor will be given in the evening prior to receiving 10µg/kg G-CSF and undergoing apheresis the next morning for up to 3 days of apheresis or until ≥ 5x10(6) cells/kg are collected.
if the patient's peripheral CD34+ cell count is 7 to 19 cells/ul (inclusive), apheresis will be done. If the apheresis yield is < 1.3x10(6) CD34+ cells/kg then 240ug/kg Plerixafor will be given in the evening prior to receiving 10 µg/kg G-CSF and undergoing apheresis the next morning. If the apheresis yield is at least double that on Day 5, Plerixafor followed the next morning by G-CSF and apheresis will be repeated for up to a total of 3 days of apheresis or until 5x10(6) cells/kg are collected.
Other intervention name(s): Mozobil, AMD3100
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NHL