AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts
Condition: Autologous Stem Cell Transplantation
Intervention: G-CSF plus plerixafor
Intervention description: Participants underwent mobilization with granulocyte colony-stimulating factor (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 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Non-Hodgkin's Lymphoma; autologous transplantation; AMD3100; stem cell mobilization; plerixafor

Summary:

      This study evaluates the safety, efficacy, and pharmacokinetics (PK) 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 who would benefit from an
      autologous stem cell transplant but have failed previous collections or collection attempts
      with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional
      therapy including cytokines, chemotherapy and cytokines and bone marrow harvests.

      The only change to standard of care of a mobilization regimen that includes G-CSF is the
      addition of a dose of AMD3100 (plerixafor) on the evening prior to each day of apheresis.

      Efficacy outcomes include quantification of CD34+ cells in the apheresis product and
      assessment of successful polymorphonuclear leukocyte (PMN) and platelet (PLT) engraftment
      after transplantation. PK outcomes include analysis of repeated doses of plerixafor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible to undergo autologous transplantation

          -  Has failed previous collections or collection attempts with a mobilization regimen of
             granulocyte colony-stimulating factor (G-CSF), chemotherapy and G-CSF or any other
             conventional therapy including cytokines, chemotherapy and cytokines or bone marrow
             harvest.

          -  Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1

          -  ≥3 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade™
             are not considered prior chemotherapy for the purpose of this study) NOTE: Although
             thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the
             purpose of this study, none are to be administered within 7 days prior to the first
             dose of G-CSF (see Exclusion Criteria).

          -  The patient has recovered from all acute toxic effects of prior chemotherapy

          -  White blood cell count (WBC) >2.5*10^9/L

          -  Absolute neutrophil count >1.5*10^9/L

          -  Platelet count >85*10^9/L

          -  Serum creatinine ≤1.5 mg/dl

          -  Creatinine clearance >60 ml/min

          -  Aspartate aminotransferase (AST), alanine transaminase (ALT) and total bilirubin <2x
             upper limit of normal (ULN)

          -  Left ventricle ejection fraction >45% (by normal echocardiogram (ECHO) or multiple
             gated acquisition (MUGA) scan)

          -  Forced expiratory volume in one minute (FEV1) >60% of predicted or diffusion lung
             capacity for carbon monoxide (DLCO) ≥45% of predicted

          -  No active infection of hepatitis B or C

          -  Negative for HIV

          -  Signed informed consent

          -  Women of child-bearing potential agree to use an approved form of contraception

        Exclusion Criteria:

          -  Once 70 patients have enrolled, patients with diagnoses other than lymphoma are not
             eligible (eg, acute myeloid leukemia, chronic lymphocytic leukemia, or multiple
             myeloma).

          -  A co-morbid condition which, in the view of the investigators, renders the patient at
             high risk from treatment complications

          -  A residual acute medical condition resulting from prior chemotherapy

          -  Received Neupogen™, thalidomide, dexamethasone, and/or Velcade™ within 7 days prior to
             the first dose of G-CSF

          -  Brain metastases or carcinomatous meningitis

          -  Acute infection

          -  Fever (temperature >38°C/100.4°F)

          -  Hypercalcaemia (>1 mg/dL above the ULN)

          -  Positive pregnancy test in female patients

          -  Lactating females

          -  Patients of child-bearing potential unwilling to implement adequate birth control

          -  Patients whose actual body weight exceeds 175% of their ideal body weight

          -  Patients who previously received experimental therapy within 4 weeks of enrolling in
             this protocol or who are currently enrolled in another experimental protocol during
             the Mobilization phase