Lenalidomide and Azacitidine for Adaptive Immunotherapy in Multiple Myeloma: Pilot Study of Autologous Lymphocyte Mobilization Following Immuno-modulatory Therapy
- Determine the feasibility of mobilizing and infusing autologous lymphocytes (ALI)
following immunomodulatory therapy comprising azacitidine and lenalidomide in patients
with multiple myeloma.
- Determine the ability to proceed with autologous stem cell transplantation in these
- 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
- 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.
- 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
- 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
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.
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
Amir A. Toor, MD
Massey Cancer Center
United States: Institutional Review Board
|Virginia Commonwealth University||Richmond, Virginia|