Stem Cell Transplantation for Patients With Multiple Myeloma

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

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).

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.