Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT03317899
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19107, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo auto HSCT
Given subcutaneously
Other names: Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Granix
Correlative Studies
Time frame: Up to 60 days
Will compare days to discharge readiness between the two groups.
Time frame: Up to 60 days
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
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
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
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests
Time frame: Up to 60 days
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time frame: Up to 60 days
Will be defined as a positive blood culture not ultimately deemed to be due to a contaminant
Time frame: Up to 60 days
Will be summarized by treatment arm and compared using Wilcoxon rank sum tests.
Time frame: Up to 60 days
will be presented as percentage of number of subjects who had the treatment
Time frame: Up to 60 days
will be presented as percentage of number of subjects who had the treatment
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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