Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
|Refractory Multiple Myeloma||Drug: plerixafor Biological: filgrastim||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide|
- Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg [ Time Frame: In =< 2 days of leukaphereses ]
- Percentage of Patients Achieving Target Goal CD34+ Cells Dose [ Time Frame: In =< 5 days of leukaphereses ]
- Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other [ Time Frame: By day 1 ]Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.
- Compare Days of Apheresis Between Mobilization Groups [ Time Frame: Day 1 ]Using the Wilcoxon Rand Sum Test
- Compare Need for Hospitalization During Mobilization Between Mobilization Groups [ Time Frame: Day 1 ]
- Compare Need for Remobilization Between Mobilization Groups [ Time Frame: Day 1 ]Using the Chi-square test or Fisher's exact test, as appropriate.
|Study Start Date:||July 2011|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive G-CSF SC QD on days 1-4.
Experimental: Arm II
Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
Other Names:Biological: filgrastim
I. Ability to reach target collection of 5 x 10^6 CD34+ cells/Kg with =< 2 days of leukaphereses using one of two mobilization regimens.
I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of leukaphereses.
II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.
III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.
ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.
After completion of study treatment, patients are followed up at 14 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301963
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Hien Duong, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Principal Investigator:||Hillard Lazarus, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|