Stem Cell Transplantation for Patients With Multiple Myeloma
- Interventional
- Active
- NCT01526096
Contact Information
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).
Gender
All
Age Group
21 Years to 70 Years
Accepting Healthy Volunteers?
No
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.
- 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.