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Stem Cell Transplantation for Patients With Multiple Myeloma

NCT01526096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Michael Bishop, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-12
Primary Completion
2024-08-28
Completion
2024-08-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526096 on ClinicalTrials.gov