A Phase 4 interventional study of plerixafor + G-CSF in Autologous Haematopoietic Stem Cell Transplant, sponsored by Sanofi. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and CD34+ cells apheresis and a follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier
Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive the first dose of plerixafor by subcutaneous (SC) injection on the evening of Day 4 (10 to 11 hours (± 1 hour) prior to the start of next day's apheresis). For a maximum of 4 days, patients will continue to receive daily plerixafor in the evening, followed by a morning dose of G-CSF and apheresis for up to a maximum of 4 apheresis or until ≥ 6×106 Cluster of differentiation 34 (CD34) + cells/kg were collected.
Drug: plerixafor + G-CSF
subcutaneous (SC) injection
The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days
Time frame: Day 5 to Day 6
the proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 4 or fewer apheresis days
Time frame: Day 5 to Day 8
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 2 or fewer apheresis days
Time frame: Day 5 to Day 6
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 4 or fewer apheresis days
Time frame: Day 5 to Day 8
the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg
Time frame: Day 5 to Day 8
Peripheral Blood CD34+ count from Day 4 to Day 5 with the venous samples for Fluorescent activated cell sorting analysis obtained on the morning of Day 4 prior to administration of G-CSF and morning of Day 5 prior to administration of G-CSF
Time frame: Day 4 to Day 5
Number of participants with Adverse events and Serious adverse events
Time frame: Baseline to Day 30 (+7 days)
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi