A Phase 1 interventional study of G-CSF and Plerixafor in Myeloma, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-05.
Sponsored by University of Chicago · Phase 1, Interventional, and Treatment
The purpose of this study is to test whether regulatory T-cell reduction is possible and safe in myeloma subjects undergoing autologous stem cell transplantation (ASCT).
2,306 studies on the registry are indexed under Neoplasms, Plasma Cell; 246 are open to participants now.
This study's enrollment of 30 is below the median of 39 across 1,823 interventional studies indexed under Neoplasms, Plasma Cell.
Browse Neoplasms, Plasma Cell studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard autologous stem cell transplantation (ASCT)
Drug: G-CSF · Drug: Plerixafor · Procedure: Apheresis · Drug: Melphalan · Procedure: Stem cell re-infusion
Standard ASCT followed by treatment with basiliximab to remove certain immune cells (called regulatory T-cells or Tregs) from the blood
Drug: G-CSF · Drug: Plerixafor · Procedure: Apheresis · Drug: Melphalan · Procedure: Stem cell re-infusion · Drug: Basiliximab
Blood collected for an ASCT will be processed using a special cell sorting machine (CliniMACS device) to remove Treg cells before the stem cells are infused back into the body during stem cell transplant.
Drug: G-CSF · Drug: Plerixafor · Procedure: Apheresis · Drug: Melphalan · Procedure: Stem cell re-infusion · Device: CliniMACS CD25 microbeads and cell sorter
G-CSF will be self-administered shot daily for 4 days pre-transplant. Up to 8 doses of G-CSF may be given. G-CSF will also be administered once daily under the skin beginning 5 days after your stem cell infusion until your white blood cell count is high enough
Plerixafor (self-administered shot)prior to the beginning of the stem cell collection. Up to 4 doses of plerixafor may be given.
Stem cell collection begins on day 5 and can last up to 3 days depending on the number collected.
Melphalan chemotherapy 100mg/m2 for 2 days after your admission into the hospital for your ASCT procedure.
Also known as: Alkeran
Stem cells are thawed and reinfused back into the body via a catheter in the vein.
Basiliximab (20mg) given by IV infusion (through the vein) 20-30 minutes the day after ASCT.
Also known as: Simulect
The stem cells collected during apheresis will be counted and treated with CD25 microbeads and processed by a special device called a CliniMACs machine which removes the regulatory T cells from you stem cell product.
Purity of ex vivo depleted regulatory T cells prior to autologous stem cell transplant (arm 3 only)
Percentage of CD4+CD25+ regulatory T cells following ex vivo depletion in arm 3 will be analyzed by flow cytometry and compared to a pre-CD25-depletion sample. The depletion of CD25+ cells among the entire CD4+ population is expected to reach 80% efficiency.
Time frame: 1-3 days
Timing and duration of regulatory T cell depletion and recovery following autologous stem cell transplant
Timing and duration of regulatory T cell depletion and recovery following in vivo or ex vivo (arms 2 and 3) CD25+ T cell depletion will be performed at pre-defined timepoints prior to and following autologous stem cell transplant by flow cytometry on peripheral blood samples and directly compared to the percentages of regulatory T cells (CD4+CD25+FoxP3+ or CD4+CD25+CD127-) present at the same timepoints in patients enrolled onto arm 1 in which no regulatory T cell depletion is performed.
Time frame: 180 days
Incidence of autologous graft-versus-host disease following in vivo or ex vivo regulatory T cell depletion
The indicence of autologous graft-versus-host disease, as assessed by the development of skin rash, diarrhea and/or liver function test abnormalities consistent with autologous graft-versus-host disease following CD25+ T cell depletion and autologous stem cell transplant compared with the incidence of autologous graft-versus-host disease in patients enrolled onto arm 1 in which no regulatory T cell depletion is performed.
Time frame: 180 days
Kinetics of recovery of peripheral blood cellular elements
Time to recovery of neutrophils and platelets will be analyzed by daily complete blood counts following autologous stem cell transplant. Patients enrolled onto arms 2 and 3 (in vivo and ex vivo regulatory T cell depletion, respectively) will be directly compared to patients enrolled onto arm 1 in which no regulatory T cell depletion is performed.
Time frame: 180 days
Number of patients that experience a complete response following autologous stem cell transplant based upon the assigned study arm using International Myeloma Working Group definitions
The complete response rate following autologous stem cell transplant with or without regulatory T cell depletion will be analyzed and compared directly between study arms.
Time frame: 100 days
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University of Chicago