Clinical trial NCT00322387: Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Multiple Myeloma
Keywords: Non-Hodgkin's Lymphoma
Multiple Myeloma
Stem cell mobilization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
timeFrame: 13 months
Secondary outcomes:
measure: Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
timeFrame: Days 4-5 (first dose of plerixafor to apheresis)
measure: 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
timeFrame: 2 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Beech Grove
country: United States
facility: Indiana Blood and Marrow Transplantation
state: Indiana
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.