Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
2 other identifiers
interventional
302
3 countries
39
Brief Summary
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Jan 2005
Shorter than P25 for phase_3 multiple-myeloma
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 11, 2005
CompletedFirst Posted
Study publicly available on registry
February 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
September 29, 2010
CompletedMarch 13, 2014
February 1, 2014
1.7 years
February 11, 2005
February 2, 2009
February 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Proportion of participants achieving a target of ≥ 6\*10\^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
up to Day 6
Secondary Outcomes (9)
Number of Participants With Adverse Events
up to Day 38
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
up to Day 8
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
up to Day 8
Median Number of Days to ≥6*10^6 CD34+ Cells/kg
up to Day 8
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Up to Month 13
- +4 more secondary outcomes
Study Arms (2)
G-CSF plus plerixafor
EXPERIMENTALG-CSF plus placebo
PLACEBO COMPARATORInterventions
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Eligibility Criteria
You may qualify if:
- Diagnosis of multiple myeloma in first or second complete or partial remission
- \>= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
- Recovered from all acute toxic effects of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White Blood Cell count (WBC) \> 2.5\*10\^9/L
- Absolute polymorphonuclear leukocytes (PMN) count \> 1.5\*10\^9/L
- Platelet (PLT) \> 100\*10\^9/L
- Serum creatinine \<=2.2 mg/dL
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
You may not qualify if:
- Failed previous stem cell collection
- Previous stem cell transplantation
- Brain metastases or myelomatous meningitis
- Radiation to ≥ 50% of the pelvis
- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
- Received bone-seeking radionuclides (e.g. holmium)
- A residual acute medical condition resulting from prior chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
City of Hope Samaritan Bone Marrow Transplant Program
Phoenix, Arizona, 85006, United States
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Cedars-Sinai
Los Angeles, California, 90048, United States
University of California
Los Angeles, California, 90095, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32611, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana Blood and Marrow Transplantation Center
Beech Grove, Indiana, 46107, United States
University of Iowa Hosptials and Clinics
Iowa City, Iowa, 52242, United States
Fairview-University Medical Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kansas City Cancer Center
Kansas City, Missouri, 64111, United States
Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
St Louis, Missouri, 63110, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
New York Hospital
New York, New York, 10032, United States
Memorial Sloan Kettering
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Utah Blood and Marrow Transplant Program, University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Universitätsklinikum Heidelberg,
Heidelberg, 69120, Germany
Related Publications (1)
DiPersio JF, Stadtmauer EA, Nademanee A, Micallef IN, Stiff PJ, Kaufman JL, Maziarz RT, Hosing C, Fruehauf S, Horwitz M, Cooper D, Bridger G, Calandra G; 3102 Investigators. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009 Jun 4;113(23):5720-6. doi: 10.1182/blood-2008-08-174946. Epub 2009 Apr 10.
PMID: 19363221RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Genzyme Medical Information
- Organization
- Genzyme Corporation
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 11, 2005
First Posted
February 14, 2005
Study Start
January 1, 2005
Primary Completion
October 1, 2006
Study Completion
January 1, 2008
Last Updated
March 13, 2014
Results First Posted
September 29, 2010
Record last verified: 2014-02