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

NCT ID: NCT00395967

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-08-31

Brief 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).

Detailed Description

A Phase 2, single-center, open-label study to assess the safety and hematological activity of 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. The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis.

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

On Day 5, if the patient's peripheral CD34+ cell count was <5 cells/µl or ≥20 cells/µl, the patient did not enter this study and was treated as per the policy of the study site.

On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg are collected.

On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive), then he/she underwent apheresis that day. If this apheresis yield was <1.3*10^6 CD34+ cells/kg, then the patient was predicted to be unlikely to collect ≥2*10^6 CD34+ cells/kg in ≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the apheresis yield on Day 5 was ≥1.3*10^6 CD34+ cells/kg, then the patient did not enter the study.

The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis yield was at least double the apheresis yield on Day 5, then the patient received another 10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg were collected.

All patients, after the completion of apheresis procedures (or after ≥5*10^6 cells/kg were collected), received high-dose chemotherapy in preparation for transplantation. Patients were transplanted with cells collected after receiving plerixafor with G-CSF. However, if there were insufficient cells, cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone.

Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells harvested during apheresis.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin's

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All Patients

Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\*10\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.

Group Type: EXPERIMENTAL

G-CSF plus plerixafor

Intervention Type: DRUG

Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

Interventions

G-CSF plus plerixafor

Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

Intervention Type: DRUG

Other Intervention Names

Mozobil; AMD3100

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Duke University Medical Center - Adult BMT Program

Durham, North Carolina, United States

Countries

United States

Other Identifiers

AMD3100-2109

Identifier Type: -

Identifier Source: org_study_id