AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
Condition: Multiple Myeloma; Lymphoma, Non-Hodgkin's
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Intervention: G-CSF plus plerixafor
Intervention description: Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; Multiple Myeloma; stem cell mobilization; autologous transplantation; AMD3100

Summary:

      This Phase 2 study was designed to assess the safety and hematological activity of AMD3100
      (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were
      predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. Patients
      with NHL and MM were eligible to enter the study if they had undergone cyto-reductive
      chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion
      criteria.

      The purpose of this protocol was to determine whether plerixafor in combination with
      Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of
      peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low
      after treatment with G-CSF alone, whether it was safe, and whether transplantation with the
      apheresis product was successful, as measured by time to engraftment of polymorphonuclear
      leukocytes (PMNs) and platelets (PLTs).
    

Eligibility criteria:

        Inclusion Criteria (Abbreviated List):

          -  Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM)

          -  Eligible for autologous transplantation

          -  <=3 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the
             purpose of this study)

          -  >4 weeks since last cycle of chemotherapy (Rituxan is not considered chemotherapy for
             the purpose of this study)

          -  Total dose of melphalan ≦200 mg

          -  Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1

          -  White blood cell (WBC) count >3.0*10^9/L prior to first dose of G-CSF

          -  Absolute polymorphonuclear leukocyte (PMN) count >1.5*10^9/L prior to first dose of
             G-CSF

          -  Platelet (PLT) count >100*10^9/L prior to first dose of granulocyte colony-stimulating
             factor (G-CSF)

          -  Serum creatinine ≥2.2 mg/dL

          -  SGOT, SGPT and total bilirubin <2 times upper limit of normal (ULN)

          -  Negative for HIV

          -  CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with
             G-CSF alone

        Exclusion Criteria (Abbreviated List):

          -  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

          -  Received prior radio-immunotherapy with Zevalin or Bexxar

          -  Received bone-seeking radionuclides (e.g., holmium)

          -  Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first
             dose of G-CSF

          -  History of ventricular arrhythmias, including electrocardiogram (ECG)-documented
             premature ventricular contractions (PVCs), during the last 3 years

          -  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

          -  Had an apheresis yield >1.3*10^6 CD34+ cells/kg on Day 5 (Applicable only to patients
             who, after 5 days of G-CSF mobilization, have peripheral blood (PB) CD34+ count of
             8-19 cells/µl inclusive).