drugset / Trial / NCT05087212

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients

NCT05087212

Phase 4 Completed 53 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-10-22
Primary completion
2022-12-06
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule Subcutaneous