Stem Cell Transplantation for Patients With Multiple Myeloma

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)

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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