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Pilot Study T Cell Depletion in the Setting of Autologous Stem Cell Transplantation for Patients With Multiple Myeloma

21 Years
70 Years
Open (Enrolling)

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Trial Information

Pilot Study T Cell Depletion in the Setting of Autologous Stem Cell Transplantation for Patients With Multiple Myeloma

Inclusion Criteria:

- Symptomatic multiple myeloma of any subtype in any disease stage, providing that
patient does not have smoldering myeloma.

- Patient must otherwise be a candidate for ASCT as determined by treating physician.

- No current CNS Myeloma at time of enrollment.

- Life expectancy greater than 12 weeks.

- Age greater than or equal to 21 and less than or equal to 70 years old.

- EGOG performance status less than or equal to 2.

- No cardiac, pulmonary, hepatic, or renal contraindications for high dose

- HIV Negative.

- No active Hepatitis B or C.

- Patients must be able to provide written informed, consent.

Exclusion Criteria:

- Pregnant or nursing women. Women of child-bearing age must be tested for pregnancy.

- Use of systemic immunosuppressive medications, including corticosteroids, tacrolimus,
mycophenolate mofetil, sirolimus or cyclosporine A.

- Psychiatric illness which may make compliance to the clinical protocol unmanageable
or which may compromise the ability of the patient to give informed consent.

- Active autoimmune disease including but not limited to: rheumatoid arthritis
inflammatory bowel disease, celiac disease, systemic lupus erythematosis, scleroderma
or multiple sclerosis.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Purity of ex vivo depleted regulatory T cells prior to autologous stem cell transplant (arm 3 only)

Outcome Description:

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.

Outcome Time Frame:

1-3 days

Safety Issue:


Principal Investigator

Justin Kline, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

June 2015

Related Keywords:

  • Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Chicago Chicago, Illinois  60637