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).