Stem Cell Transplantation for Patients With Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-09-12
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Basiliximab; JM 3100; Melphalan; Plerixafor

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.