An interventional study of Plerixafor in Multiple Myeloma and Non-Hodgkins Lymphoma, sponsored by Shi, Patricia, M.D.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-09-27.
Sponsored by Shi, Patricia, M.D. · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.
The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis. This is a logistical problem, since plerixafor should be administered by a health care provider, given the risk of hypotension with administration. The primary purpose of this study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether the dosing interval can be increased to 16 hours prior to apheresis. Patients will be admitted to a special clinical research center on the 4th day of G-CSF administration, where the peripheral blood CD34+ count will be measured every 2 hours after plerixafor administration at 5 pm until 9 AM the following day, at which time apheresis will commence. The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and effective as plerixafor administration at 11 hours prior to apheresis.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 10 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →This is the only study on the registry with Shi, Patricia, M.D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Plerixafor 16 hours
Drug: Plerixafor
Plerixafor administered at 16 hours prior to apheresis
Also known as: Mozobil
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
Time frame: After collection
Median and average neutrophil and platelet engraftment
Time frame: After stem cell infusion
Plerixafor-related toxicities
Time frame: 1 month after stem cell infusion
This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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