This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.
PRIMARY OBJECTIVE: I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support. SECONDARY OBJECTIVE: I. To compare days to absolute neutrophil count (ANC) \> 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support. EXPLORATORY OBJECTIVE: I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Undergo auto HSCT
Given subcutaneously
Correlative Studies
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Number of Days to Discharge
Will compare days to discharge readiness between the two groups.
Time frame: Up to 60 days
Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment
Will be defined as absolute neutrophil count \> 500 x 10\^9/L x 3 days. Day of engraftment is the first of the 3 days of absolute neutrophil count \> 500 x 10\^9/L.
Time frame: Up to 60 days
Median Days Post Auto HSCT to Platelet Engraftment
Will be defined as date platelet greater than or equal to 20 x 10\^9 /L without a platelet transfusion within the last 7 days.
Time frame: Up to 60 days
Percentage of Participants With Engraftment Syndrome
Will be defined by the Maiolino Criteria. Will be summarized by treatment arm and compared using a chi-square test
Time frame: Up to 60 days
Median Number of Febrile Days During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Time frame: Up to 60 days
Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time frame: Up to 60 days
Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
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Time frame: Up to 60 days
Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time frame: Up to 60 days
Percentage of Participants Receiving Corticosteroids
will be presented as percentage of number of subjects who had the treatment
Time frame: Up to 60 days
Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT
will be presented as percentage of number of subjects who had the treatment
Time frame: Up to 60 days