A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma

Inclusion Criteria

Criteria

- Inclusion and exclusion criteria must be re-evaluated prior to dosing with
PLERIXAFOR; if the patient does not meet any of these criteria (excluding the hepatic
and hematologic criteria) the patient is not eligible to continue unless Genzyme
grants a waiver

Inclusion

- Eligible to undergo autologous transplantation

- Diagnosed with multiple myeloma (MM)

- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1

- The patient has recovered from all acute toxic effects of prior chemotherapy

- White Blood Count (WBC) > 2.5 x 10^9/L

- Absolute neutrophil count >1.5 x 10^9/L

- Platelet count > 100 x 10^9/L

- Serum creatinine <= 2.5 mg/dl

- Creatinine clearance >= 50 ml/min (measured or calculated)

- Serum glutamic oxaloacetic transaminase (SGOT) < 2 x ULN (Upper Limit of Normal)

- Serum glutamic pyruvic transaminase (SGPT) < 2 x ULN

- Total bilirubin < 2 x ULN

- Left ventricle ejection fraction > 45% [by normal ECHO (Echocardiogram) or MUGA
(MUltiple Gated Acquisition) scan]

- FEV1 (forced expiratory volume in 1 second) > 60% of predicted or DLCO (Carbon
Monoxide Diffusing Capacity )> 55% of predicted

- No active infection of hepatitis B or C

- Negative for HIV

- Signed informed consent (may be obtained anytime prior to admission for cytoxan)

- Women of child bearing potential agree to use an approved form of contraception

Exclusion

- 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

- Brain metastases or carcinomatous meningitis

- Acute infection

- Fever (temp > 38 degrees C/100.4 degrees F)

- Positive pregnancy test in female patients

- Lactating females

- Patients of child-bearing potential unwilling to implement adequate birth control

- Prior treatment with Plerixafor

- Prior stem cell transplant, either autologous or allogeneic

- Prior cyclophosphamide priming

- Heart rate < 50 at screening

- Abnormal ECG (electrocardiogram) with a clinically significant rhythm disturbance or
conduction abnormality that in the opinion of the investigator warrants exclusion of
the subject from the trial

- Patients with congestive heart failure at screening

- History of atrial fibrillation

- Patients who are currently on medication to control cardiac arrhythmias