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Stem Cell Transplantation for Patients With Multiple Myeloma

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The University of Chicago

Status and phase

Active, not recruiting
Phase 1

Conditions

Myeloma

Treatments

Device: CliniMACS CD25 microbeads and cell sorter
Drug: Basiliximab
Drug: Melphalan
Drug: Plerixafor
Procedure: Apheresis
Drug: G-CSF
Procedure: Stem cell re-infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01526096
10-551-B

Details and patient eligibility

About

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).

Enrollment

15 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 3 patient groups

Standard ASCT (Grp 1)
Active Comparator group
Description:
Standard autologous stem cell transplantation (ASCT)
Treatment:
Procedure: Stem cell re-infusion
Drug: G-CSF
Procedure: Apheresis
Drug: Plerixafor
Drug: Melphalan
Depletion of T-cells after ASCT (Grp 2)
Experimental group
Description:
Standard ASCT followed by treatment with basiliximab to remove certain immune cells (called regulatory T-cells or Tregs) from the blood
Treatment:
Procedure: Stem cell re-infusion
Drug: G-CSF
Procedure: Apheresis
Drug: Plerixafor
Drug: Melphalan
Drug: Basiliximab
Depletion of T-cells before ASCT(Grp 3)
Experimental group
Description:
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.
Treatment:
Procedure: Stem cell re-infusion
Drug: G-CSF
Procedure: Apheresis
Drug: Plerixafor
Drug: Melphalan
Device: CliniMACS CD25 microbeads and cell sorter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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