Stem Cell Transplantation for Patients With Multiple Myeloma

Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01526096
• Other study ID #: 10-551-B
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 12, 2011
• Est. completion date: September 12, 2025

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: September 12, 2025
• Est. primary completion date: September 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

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

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

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

Procedure:
• Stem cell re-infusion
Stem cells are thawed and reinfused back into the body via a catheter in the vein.

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

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Purity of ex vivo depleted regulatory T cells prior to autologous stem cell transplant (arm 3 only)	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.	1-3 days
Primary	Timing and duration of regulatory T cell depletion and recovery following autologous stem cell transplant	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.	180 days
Primary	Incidence of autologous graft-versus-host disease following in vivo or ex vivo regulatory T cell depletion	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.	180 days
Secondary	Kinetics of recovery of peripheral blood cellular elements	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.	180 days
Secondary	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	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.	100 days