Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

NCT ID: NCT00322387

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-07-31

Brief Summary

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Detailed Description

An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.

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

Lymphoma, Non-Hodgkin; Multiple Myeloma

Study Design

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

Study Groups

Plerixafor PM

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.

Called 'Cohort A' in protocol, study report and publications.

Group Type: EXPERIMENTAL

G-CSF and plerixafor

Intervention Type: DRUG

G-CSF and plerixafor were administered as described in the treatment arms.

Plerixafor AM

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Called 'Cohort B' in protocol, study report and publications.

Group Type: EXPERIMENTAL

G-CSF and plerixafor

Intervention Type: DRUG

G-CSF and plerixafor were administered as described in the treatment arms.

Low CD34+ Count/ Plerixafor PM

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Called 'Cohort C' in protocol, study report and publications.

Group Type: EXPERIMENTAL

G-CSF and plerixafor

Intervention Type: DRUG

G-CSF and plerixafor were administered as described in the treatment arms.

Plerixafor After Chemo

This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Called 'Investigational Cohort' in protocol, study report and publications.

Group Type: EXPERIMENTAL

G-CSF and plerixafor

Intervention Type: DRUG

G-CSF and plerixafor were administered as described in the treatment arms.

Interventions

G-CSF and plerixafor

G-CSF and plerixafor were administered as described in the treatment arms.

Intervention Type: DRUG

Other Intervention Names

Mozobil; AMD3100

Eligibility Criteria

Inclusion Criteria

• MM in first partial response/complete response, first relapse, or second partial/complete response
• NHL in first or second partial or complete remission
• NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
• MM patients who have stable disease with < 40% bone marrow involvement
• No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• White blood cell count (WBC) >3.0 x 10^9/L
• Absolute neutrophil count >1.5 x 10^9/L
• Platelet count >100 x 10^9/L

Exclusion Criteria

• Brain metastases or carcinomatous meningitis
• Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
• Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
• Acute Infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

City of Hope National Medical Center

Duarte, California, United States

Indiana Blood and Marrow Transplantation

Beech Grove, Indiana, United States

University of Rochester Medical Center

Rochester, New York, United States

Oregon Health and Science University

Portland, Oregon, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

References

Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory trial in patients with multiple myeloma and non-Hodgkin's lymphoma undergoing stem cell mobilization. Bone Marrow Transplant. 2010 Jan;45(1):39-47. doi: 10.1038/bmt.2009.119. Epub 2009 Jun 1.

Reference Type: RESULT

PMID: 19483760 (View on PubMed)

Other Identifiers

AMD3100-2104

Identifier Type: -

Identifier Source: org_study_id