Stem Cell Transplantation for Patients With Multiple Myeloma

  • Interventional
  • Not Recruiting
  • NCT01526096
Eligibility Details Visit Clinicaltrials.gov

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.

At a Glance

National Government IDNCT01526096

IRB#10-551-B

Lead SponsorUniversity of Chicago

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
21 Years to 70 Years
Not Recruiting