• To assess, among patients with a circulating CD34+ count <20 cells/µl after 5 days of mobilization with G-CSF alone, the percentage of patients who achieve ≧2 x 10e6 CD34+ cells/kg within 3 days of apheresis after receiving AMD3100 with G-CSF.
  

• To evaluate if AMD3100 is generally safe.
  
• To investigate the hematological activity of AMD3100.
  
• To determine the times of PMN and PLT engraftment.
  
• To determine the durability of engraftment.
  

This is a Phase 2, observational, single-center, open-label study to further assess the safety and hematological activity of AMD3100 in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who are predicted to be unable to mobilize ≧2 x 10e6 CD34+ cells/kg within 3 apheresis days. NHL and MM patients who have undergone a cyto reductive chemotherapy regimen protocol, who are to undergo autologous transplantation, and who meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of AMD3100 to a G-CSF mobilization regimen on the day prior to apheresis.

Following screening procedures, eligible patients will undergo mobilization with G-CSF (10 µg/kg qd) for 5 days and their peripheral blood (PB) CD34+ cell count will be measured on the fifth day.

On Day 5, if the patient's peripheral CD34+ cell count is <5 cells/µl or ≧20 cells/µl, then he/she will not enter this study and will be treated as per the policy of the study site.

On Day 5, if the patient's peripheral CD34+ cell count is 5 to 7 cells/µl (inclusive), then he/she will not undergo apheresis that day, but will receive a dose of 240 µg/kg AMD3100 in the evening (approximately 10:00 pm) prior to receiving G-CSF and undergoing apheresis the next morning. The evening dosing with AMD3100 followed the next morning by G-CSF and apheresis will be repeated for up to a total of 3 days of apheresis or until ≧5 x 10e6 cells/kg are collected.

On Day 5, if the patient's peripheral CD34+ cell count is 8 to 19 cells/µl (inclusive), then he/she will undergo apheresis that day. If this apheresis yield is <1.3 x 10e6 CD34+ cells/kg then the patient is predicted to be unlikely to collect ≧2 x 10e6 CD34+ cells/kg in ≦3 days of apheresis and he/she may enter the study; he/she will receive a dose of 240 µg/kg AMD3100 that evening at approximately 10:00 pm. However, if the apheresis yield on Day 5 is ≧1.3 x 10e6 CD34+ cells/kg, then the patient will not enter the study.

The next morning (Day 6), eligible patients will receive a dose of G-CSF (10 µg/kg) and will begin apheresis approximately 10 to 11 hours after the previous evening AMD3100 dose. If the apheresis yield is at least double the apheresis yield on Day 5, then he/she will receive another 10:00 pm dose of AMD3100 and have another apheresis performed the next morning (Day 7) after receiving G-CSF. The patient will repeat the evening dose of AMD3100 followed the next morning by G-CSF and apheresis for up to a total of 3 days of apheresis or until ≧5 x 10e6 cells/kg are collected.

All patients, after the completion of apheresis procedures (or after ≧5 x 10e6 cells/kg are collected), will be treated with high-dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells collected after receiving AMD3100 with G-CSF. However, if there are insufficient cells, then cells collected after receiving AMD3100 with G-CSF may be pooled with cells collected after receiving G-CSF alone.

Safety will be evaluated by physical exam, adverse events/serious adverse events, concomitant medications, injection site assessment, hematology, chemistry, and urinalysis.

Hematological activity of AMD3100 will be evaluated by the number of CD34+ cells mobilized in the peripheral blood just prior to the time of the AMD3100 dosing and prior to apheresis, and the number of CD34+ cells harvested in the apheresis product. In addition, success of the transplantation will be evaluated by the times to PMN and PLT engraftment and by graft durability.

Inclusion Criteria:

• Diagnosis of NHL or 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
• ECOG performance status of 0 or 1
• Recovered from all acute toxic effects of prior chemotherapy
• WBC count >3.0 x 10e9/l prior to first dose of G-CSF
• Absolute PMN count >1.5 x 10e9/l prior to first dose of G-CSF
• PLT count >100 x 10e9/l prior to first dose of G-CSF
• Serum creatinine ≦2.2 mg/dl
• SGOT, SGPT and total bilirubin <2 x upper limit of normal (ULN)
• Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
• Negative for HIV
• Signed informed consent
• Patients of childbearing potential agree to use an approved form of contraception
• CD34+ cell count between 5 and 19 CD34+ cells/ml after 5 days of mobilization with G CSF alone

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
• 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
• Fever (temperature >38 °C/100.4 °F)
• Positive pregnancy test in female patients
• Lactating females
• History of ventricular arrhythmias, including ECG-documented 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
• (Applicable only to patients who, after 5 days of G-CSF mobilization, have PB CD34+ count of 8-19 cells/µl inclusive) Had an apheresis yield ≧1.3 x 10e6 CD34+ cells/kg on Day 5.