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
Intervention: G-CSF plus Plerixafor
Intervention description: 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.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: NHL

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 75 years.

          -  Diagnosis of NHL, HD or MM

          -  Eligible for autologous transplantation

          -  CD34+ cell count < 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell
             count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and < 1.3 x 106
             CD34+ cells collected by apheresis on day 5 of G-CSF therapy.

          -  < or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy
             for the purpose of this study)

          -  ≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization
             (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this
             study)

          -  Total dose of melphalan < or equal to 200 mg

          -  ECOG performance status of 0 or 1

          -  Recovered from all acute toxic effects of prior chemotherapy

          -  Absolute PMN count > 1.0 X 10(9)/l prior to first dose of G-CSF

          -  PLT count > 75 X 10(9)/l prior to first dose of G-CSF

          -  Serum creatinine < or equal to 2.5 mg/dl

          -  SGOT, SGPT and total bilirubin < 2 X upper limit of normal (ULN) prior to the first
             dose of G-CSF

          -  Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as
             determined by standard institutional practice

          -  Signed informed consent

          -  Patients of childbearing potential agree to use an approved form of contraception

        Exclusion Criteria:

          -  A co-morbid condition which, in the view of the investigator, renders the patient at
             high risk from treatment complications

          -  Failed previous stem cell collection or collection attempts

          -  A residual acute medical condition resulting from prior chemotherapy

          -  Active brain metastases or carcinomatous meningitis

          -  Active infection requiring antibiotic treatment (excluding controlled catheter-related
             bacteremia)

          -  Received prior radio-immunotherapy with Zevalin or Bexxar

          -  Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first
             dose of G-CSF

          -  Positive pregnancy test in female patients

          -  Lactating females

          -  Patients who previously received experimental therapy within 4 weeks of enrolling in
             this protocol