Lenalidomide and Azacitidine for Adaptive Immunotherapy in Multiple Myeloma: Pilot Study of Autologous Lymphocyte Mobilization Following Immuno-modulatory Therapy
OBJECTIVES:
Primary
- Determine the feasibility of mobilizing and infusing autologous lymphocytes (ALI)
following immunomodulatory therapy comprising azacitidine and lenalidomide in patients
with multiple myeloma.
Secondary
- Determine the ability to proceed with autologous stem cell transplantation in these
patients.
- Determine the complete response rate at 6 months following transplant in patients
treated with this regimen.
- Determine the progression-free survival and overall survival of patients treated with
this regimen.
- Determine the time to progression in patients treated with this regimen.
- Monitor the toxicity of post-autologous stem cell infusion of autologous lymphocytes.
- Measure the pre- and post-ALI immune response to cancer testis antigens (CTA)
(CTA-specific Ig and T-cell repertoire).
- Study the expression of CTA in multiple myeloma before and after azacitidine therapy.
OUTLINE:
- Immunomodulatory therapy: Patients receive azacitidine subcutaneously on days 1-5 and
oral lenalidomide on days 6-21. Treatment repeats every 28 days for up to 3 courses in
the absence of disease progression or unacceptable toxicity.
- Lymphapheresis: Patients undergo autologous lymphocyte harvest on day 22 of courses 2
and 3.
- Autologous stem cell transplantation (ASCT): Patients undergo single or tandem ASCT
using standard protocols.
- Autologous lymphocyte infusion (ALI): Patients undergo ALI approximately 28-60 days
after ASCT.
Blood samples are collected at baseline and periodically during study for correlative
laboratory studies, including CTA-specific immune monitoring by RT-PCR, ELISPOT assays, and
flow cytometry. Tissue samples from bone marrow aspirates are also collected at baseline,
during course one, and after course three for CTA expression and methylation studies.
After completion of study therapy, patients are followed periodically.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ability to mobilize and infuse autologous lymphocytes (ALI) after immunomodulatory therapy
2 years
No
Amir A. Toor, MD
Principal Investigator
Massey Cancer Center
United States: Institutional Review Board
CDR0000663409
NCT01050790
January 2010
January 2017
Name | Location |
---|---|
Virginia Commonwealth University | Richmond, Virginia |