Overview

AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone

Status:
Terminated
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genzyme, a Sanofi Company
Treatments:
JM 3100
Lenograstim
Plerixafor
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).