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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322387
• Other study ID #: AMD3100-2104
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2006
• Last updated: February 10, 2014
• Start date: April 2004
• Est. completion date: July 2006

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United States	Indiana Blood and Marrow Transplantation	Beech Grove	Indiana
United States	City of Hope National Medical Center	Duarte	California
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant	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.	13 months	Yes
Secondary	Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL	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).	Days 4-5 (first dose of plerixafor to apheresis)	No
Secondary	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	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.	2 months	No