Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF 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
Intervention: G-CSF Plus Plerixafor
Intervention description: 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.
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: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; Multiple Myeloma; Stem cell mobilization

Summary:

      This study evaluates the safety and efficacy 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 with non-Hodgkin's lymphoma (NHL) and
      multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating
      CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor
      (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN)
      engraftment after transplantation. Data from this protocol will assist in the determination
      of the dosing schedule for future studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for
             autologous transplantation

          -  No more than 3 prior regimens of chemotherapy

          -  More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute
             toxic effects of prior chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  White blood cell (WBC) count >3.0*10^9/L

          -  Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L

          -  Platelet (PLT) count >100*10^9/L

          -  Serum creatinine <=2.2 mg/dL

          -  Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase
             (SGPT) and total bilirubin <2 x upper limit of normal (ULN)

          -  Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated
             acquisition (MUGA) scan

          -  Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or
             diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted

          -  Negative for human immunodeficiency virus (HIV) type 1

          -  Women of child bearing potential agreed to use an approved form of contraception.

        Exclusion Criteria:

          -  Patients who have failed previous collections

          -  Brain metastases or carcinomatous meningitis

          -  History of ventricular arrhythmias

          -  A co-morbid condition which, in the view of the investigator, renders the patient at
             high risk for treatment complications

          -  A residual acute medical condition resulting from prior chemotherapy

          -  Acute infection

          -  Fever (temp >38°C/100.4°F)

          -  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 study or who are currently enrolled in another experimental study during the
             mobilization period

          -  Positive pregnancy test in female patients

          -  Lactating females

          -  Patients of child-bearing potential unwilling to implement adequate birth control.

          -  Patients who have deterioration of their clinical status or laboratory parameters
             between the time of enrolment and transplant (such that they no longer meet entry
             criteria) may be removed from study at the discretion of the treating physician,
             principal investigator, or sponsor.