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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00322387
First received: May 4, 2006
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Multiple Myeloma
Drug: G-CSF and plerixafor
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.


Secondary Outcome Measures:
  • Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL [ Time Frame: Days 4-5 (first dose of plerixafor to apheresis) ] [ Designated as safety issue: No ]
    The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).

  • Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.


Enrollment: 40
Study Start Date: April 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Other Names:
  • Mozobil
  • AMD3100
Experimental: 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.

Drug: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Other Names:
  • Mozobil
  • AMD3100
Experimental: 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.

Drug: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Other Names:
  • Mozobil
  • AMD3100
Experimental: 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.

Drug: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Other Names:
  • Mozobil
  • AMD3100

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Abbreviated List):

  • 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 (Abbreviated List):

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322387

Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States
United States, Indiana
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, United States
United States, New York
University of Rochester Medical Center
Rochester, New York, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Publications:
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00322387     History of Changes
Other Study ID Numbers: AMD3100-2104
Study First Received: May 4, 2006
Results First Received: June 15, 2010
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Non-Hodgkin's Lymphoma
Multiple Myeloma
Stem cell mobilization

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014