Know Cancer

or
forgot password

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


Phase 3
18 Years
78 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.

Outcome Description:

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.

Outcome Time Frame:

up to Day 6

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD3100-3102

NCT ID:

NCT00103662

Start Date:

January 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Loyola University Medical CenterMaywood, Illinois  60153
University of Rochester Medical CenterRochester, New York  14642
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Rocky Mountain Cancer CenterDenver, Colorado  80218
City of Hope National Medical CenterLos Angeles, California  91010
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
University of FloridaGainesville, Florida  32610-0277
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Case Western Reserve UniversityCleveland, Ohio  44106
Emory UniversityAtlanta, Georgia  30322
University of Texas Health Science CenterSan Antonio, Texas  78284
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Ohio State UniversityColumbus, Ohio  43210
Fairview-University Medical Center, University of MinnesotaMinneapolis, Minnesota  55455
Texas Transplant InstituteSan Antonio, Texas  78229
Virginia Commonwealth UniversityRichmond, Virginia  
Yale University School Of MedicineNew Haven, Connecticut  06520
Kansas City Cancer CenterKansas City, Missouri  64111
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
University of CaliforniaSan Francisco, California  94108
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Memorial Sloan KetteringNew York, New York  10021
City of Hope Samaritan Bone Marrow Transplant ProgramPhoenix, Arizona  85006
Indiana Blood and Marrow Transplantation CenterBeech Grove, Indiana  46107
Myeloma Institute for Research and Therapy, University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Cedars-SinaiLos Angeles, California  90048
University of Iowa Hosptials and ClinicsIowa City, Iowa  52242
Washington University School of Medicine, Division of Bone Marrow Transplantation and LeukemiaSaint Louis, Missouri  63110
New York HospitalNew York, New York  10032
Utah Blood and Marrow Transplant Program, University of UtahSalt Lake City, Utah  84132