Status:
COMPLETED
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
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 mo...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00103662
Start Date
January 1 2005
End Date
January 1 2008
Last Update
March 13 2014
Active Locations (39)
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1
City of Hope Samaritan Bone Marrow Transplant Program
Phoenix, Arizona, United States, 85006
2
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
Cedars-Sinai
Los Angeles, California, United States, 90048