Status:
COMPLETED
Stem Cell Transplantation for Patients With Multiple Myeloma
Lead Sponsor:
University of Chicago
Conditions:
Myeloma
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01526096
Start Date
July 12 2011
End Date
August 28 2024
Last Update
November 5 2025
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637