Multiple Myeloma Clinical Trial
Official title:
Lenalidomide and Azacitidine for Adaptive Immunotherapy in Multiple Myeloma: Pilot Study of Autologous Lymphocyte Mobilization Following Immuno-modulatory Therapy
RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer
cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways
to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. An autologous stem cell transplant may be able to replace blood-forming cells that
were destroyed by lenalidomide and azacitidine. Giving autologous lymphocytes after the
transplant may help destroy any remaining cancer cells.
PURPOSE: This pilot trial is studying how well giving lenalidomide together with azacitidine
works when followed by autologous stem cell transplant and autologous lymphocyte infusion in
treating patients with multiple myeloma.
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.
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