Lenalidomide and Azacitidine for Adaptive Immunotherapy in Multiple Myeloma: Pilot Study of Autologous Lymphocyte Mobilization Following Immuno-modulatory Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Aza Len Lymphapheresis SCT ALI
Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
Intervention: Azacitidine (Drug)
Outcomes
Primary Outcomes
Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment
Time Frame: 6 months
Time frame is post 2nd and 3rd cycles of rev/aza and after stem cell transplant engraftment.
Secondary Outcomes
- CTA Expression Before and After Azacitidine Therapy(3 months)
- Toxicity as Assessed by NCI CTCAE v3.0(6 months)
- Time to Progression Post Transplant(28 months)
- Complete Response Rate at 6 Months(6 months)
- Progression-free and Overall Survival(1 year to 2 years)
- Pre- and Post-ALI Immune Response to Cancer Testis Antigens (CTA)(6 months)