Clinical trial NCT00103662: Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-02-14
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.

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:

* 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

Exclusion Criteria):

* 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

Primary outcomes:
measure: Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
timeFrame: up to Day 6
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: up to Day 38
measure: Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
timeFrame: up to Day 8
measure: Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
timeFrame: up to Day 8
measure: Median Number of Days to ≥6*10^6 CD34+ Cells/kg
timeFrame: up to Day 8
measure: Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
timeFrame: Up to Month 13
measure: Median Number of Days to Platelet (PLT) Engraftment
timeFrame: Up to Month 13
measure: Graft Durability at 100 Days Post Transplantation
timeFrame: approximately Day 138
measure: Graft Durability at 6 Months Post Transplantation
timeFrame: approximately Month 7
measure: Graft Durability at 12 Months Post Transplantation
timeFrame: approximately Month 13
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: City of Hope Samaritan Bone Marrow Transplant Program
state: Arizona
city: Little Rock
country: United States
facility: Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Los Angeles
country: United States
facility: University of California
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Beech Grove
country: United States
facility: Indiana Blood and Marrow Transplantation Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hosptials and Clinics
state: Iowa
city: Minneapolis
country: United States
facility: Fairview-University Medical Center, University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
state: Missouri
city: Hackensack
country: United States
facility: The Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: New York Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Lackland AFB
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Blood and Marrow Transplant Program, University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg,
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.