Clinical trial NCT01526096: Stem Cell Transplantation for Patients With Multiple Myeloma
Official title: Pilot Study T Cell Depletion in the Setting of Autologous Stem Cell Transplantation for Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Myeloma
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Purity of ex vivo depleted regulatory T cells prior to autologous stem cell transplant (arm 3 only)
timeFrame: 1-3 days
measure: Timing and duration of regulatory T cell depletion and recovery following autologous stem cell transplant
timeFrame: 180 days
measure: Incidence of autologous graft-versus-host disease following in vivo or ex vivo regulatory T cell depletion
timeFrame: 180 days
Secondary outcomes:
measure: Kinetics of recovery of peripheral blood cellular elements
timeFrame: 180 days
measure: Number of patients that experience a complete response following autologous stem cell transplant based upon the assigned study arm using International Myeloma Working Group definitions
timeFrame: 100 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael Bishop, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derman BA, Zha Y, Zimmerman TM, Malloy R, Jakubowiak A, Bishop MR, Kline J. Regulatory T-cell depletion in the setting of autologous stem cell transplantation for multiple myeloma: pilot study. J Immunother Cancer. 2020 Jan;8(1):e000286. doi: 10.1136/jitc-2019-000286.