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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03317899
Study type Interventional
Source Thomas Jefferson University
Contact
Status Completed
Phase Phase 2
Start date October 12, 2017
Completion date November 16, 2022

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