Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. This study will assess whether the combination of plerixafor and Granulocyte Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with cyclophosphamide.

PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Treatments: Cyclophosphamide; JM 3100; Lenograstim; Plerixafor; Sargramostim

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