This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Given SC
Given SC
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
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
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.
Time frame: By day 1
Compare Days of Apheresis Between Mobilization Groups
Using the Wilcoxon Rand Sum Test
Time frame: Day 1
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
Time frame: Day 1
Compare Need for Remobilization Between Mobilization Groups
Using the Chi-square test or Fisher's exact test, as appropriate.
Time frame: Day 1
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