Stem Cell Transplantation for Patients With Multiple Myeloma

NCT ID: NCT01526096

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-12
• Study Completion Date: 2024-08-28

Brief 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

Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard ASCT (Grp 1)

Standard autologous stem cell transplantation (ASCT)

Group Type: ACTIVE_COMPARATOR

G-CSF

Intervention Type: 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

Intervention Type: DRUG

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

Apheresis

Intervention Type: PROCEDURE

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

Melphalan

Intervention Type: DRUG

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

Stem cell re-infusion

Intervention Type: PROCEDURE

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

Depletion of T-cells after ASCT (Grp 2)

Standard ASCT followed by treatment with basiliximab to remove certain immune cells (called regulatory T-cells or Tregs) from the blood

Group Type: EXPERIMENTAL

G-CSF

Intervention Type: 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

Intervention Type: DRUG

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

Apheresis

Intervention Type: PROCEDURE

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

Melphalan

Intervention Type: DRUG

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

Stem cell re-infusion

Intervention Type: PROCEDURE

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

Basiliximab

Intervention Type: DRUG

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

Depletion of T-cells before ASCT(Grp 3)

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.

Group Type: EXPERIMENTAL

G-CSF

Intervention Type: 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

Intervention Type: DRUG

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

Apheresis

Intervention Type: PROCEDURE

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

Melphalan

Intervention Type: DRUG

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

Stem cell re-infusion

Intervention Type: PROCEDURE

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

CliniMACS CD25 microbeads and cell sorter

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

Plerixafor

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

Intervention Type: DRUG

Apheresis

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

Intervention Type: PROCEDURE

Melphalan

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

Intervention Type: DRUG

Stem cell re-infusion

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

Intervention Type: PROCEDURE

Basiliximab

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

Alkeran; Simulect

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bishop, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

Derman BA, Zha Y, Zimmerman TM, Malloy R, Jakubowiak A, Bishop MR, Kline J. Regulatory T-cell depletion in the setting of autologous stem cell transplantation for multiple myeloma: pilot study. J Immunother Cancer. 2020 Jan;8(1):e000286. doi: 10.1136/jitc-2019-000286.

Reference Type: DERIVED

PMID: 31940591 (View on PubMed)

Other Identifiers

10-551-B

Identifier Type: -

Identifier Source: org_study_id