Trials / Completed
CompletedNCT01526096
Stem Cell Transplantation for Patients With Multiple Myeloma
Pilot Study T Cell Depletion in the Setting of Autologous Stem Cell Transplantation for Patients With Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | G-CSF | 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 |
| DRUG | Plerixafor | Plerixafor (self-administered shot)prior to the beginning of the stem cell collection. Up to 4 doses of plerixafor may be given. |
| PROCEDURE | Apheresis | Stem cell collection begins on day 5 and can last up to 3 days depending on the number collected. |
| DRUG | Melphalan | Melphalan chemotherapy 100mg/m2 for 2 days after your admission into the hospital for your ASCT procedure. |
| PROCEDURE | Stem cell re-infusion | Stem cells are thawed and reinfused back into the body via a catheter in the vein. |
| DRUG | Basiliximab | Basiliximab (20mg) given by IV infusion (through the vein) 20-30 minutes the day after ASCT. |
| DEVICE | CliniMACS CD25 microbeads and cell sorter | 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. |
Timeline
- Start date
- 2011-07-12
- Primary completion
- 2024-08-28
- Completion
- 2024-08-28
- First posted
- 2012-02-03
- Last updated
- 2025-11-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01526096. Inclusion in this directory is not an endorsement.