Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

NCT ID: NCT00103662

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

G-CSF plus plerixafor

Group Type: EXPERIMENTAL

Granulocyte colony-stimulating factor plus plerixafor

Intervention Type: DRUG

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.

G-CSF plus placebo

Group Type: PLACEBO_COMPARATOR

Granulocyte colony-stimulating factor plus placebo

Intervention Type: DRUG

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.

Interventions

Granulocyte colony-stimulating factor plus plerixafor

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.

Intervention Type: DRUG

Granulocyte colony-stimulating factor plus placebo

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.

Intervention Type: DRUG

Other Intervention Names

Mozobil; AMD3100

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

City of Hope Samaritan Bone Marrow Transplant Program

Phoenix, Arizona, United States

Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

City of Hope National Medical Center

Duarte, California, United States

Cedars-Sinai

Los Angeles, California, United States

University of California

Los Angeles, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

University of Florida

Gainesville, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana Blood and Marrow Transplantation Center

Beech Grove, Indiana, United States

University of Iowa Hosptials and Clinics

Iowa City, Iowa, United States

Fairview-University Medical Center, University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Kansas City Cancer Center

Kansas City, Missouri, United States

Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia

St Louis, Missouri, United States

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

New York Hospital

New York, New York, United States

Memorial Sloan Kettering

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Texas Transplant Institute

San Antonio, Texas, United States

University of Texas Health Science Center

San Antonio, Texas, United States

Utah Blood and Marrow Transplant Program, University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Vancouver General Hospital

Vancouver, British Columbia, Canada

Universitätsklinikum Heidelberg,

Heidelberg, , Germany

Countries

United States; Canada; Germany

References

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.

Reference Type: RESULT

PMID: 19363221 (View on PubMed)

Related Links

http://www.nci.nih.gov/cancertopics/types/myeloma

Further information on multiple myeloma from the National Cancer Institute

Other Identifiers

2005-003599-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AMD3100-3102

Identifier Type: -

Identifier Source: org_study_id

NCT00248417

Identifier Type: -

Identifier Source: nct_alias