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Completed

NCT Number: NCT01526096

Stem Cell Transplantation for Patients With Multiple Myeloma

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).

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Key information

Conditions

Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 chemotherapy.
  • 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.

Treatment and study plan

G-CSF

Drug

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

Drug

Plerixafor (self-administered shot)prior to the beginning of the stem cell collection. Up to 4 doses of plerixafor may be given.

Apheresis

Procedure

Stem cell collection begins on day 5 and can last up to 3 days depending on the number collected.

melphalan

Drug

Melphalan chemotherapy 100mg/m2 for 2 days after your admission into the hospital for your ASCT procedure.

Other names: Alkeran

Stem cell re-infusion

Procedure

Stem cells are thawed and reinfused back into the body via a catheter in the vein.

Basiliximab

Drug

Basiliximab (20mg) given by IV infusion (through the vein) 20-30 minutes the day after ASCT.

Other names: Simulect

CliniMACS CD25 microbeads and cell sorter

Device

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.

Primary outcomes

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

    Time frame: 1-3 days

    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.

  2. Timing and duration of regulatory T cell depletion and recovery following autologous stem cell transplant

    Time frame: 180 days

    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.

  3. Incidence of autologous graft-versus-host disease following in vivo or ex vivo regulatory T cell depletion

    Time frame: 180 days

    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.

Secondary outcomes

  1. Kinetics of recovery of peripheral blood cellular elements

    Time frame: 180 days

    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.

  2. 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

    Time frame: 100 days

    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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2012
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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