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Lenalidomide and Azacitidine for Adaptive Immunotherapy in Multiple Myeloma: Pilot Study of Autologous Lymphocyte Mobilization Following Immuno-modulatory Therapy

18 Years
69 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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
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.


- 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.

Inclusion Criteria


- Diagnosis of multiple myeloma (MM)

- Has residual measurable disease* (in partial remission [PR] or with stable
disease), as defined by either of the following:

- Quantifiable levels of serum or urinary M protein or free-light chains in
the presence of a positive immunofixation

- Bone marrow plasma cells > 5% NOTE: *Isolated lytic bone lesions in the
absence of measurable para-proteins not considered measurable disease

- Not refractory to lenalidomide

- At least a PR was observed on a prior lenalidomide-containing regimen AND
patient did not progress while receiving lenalidomide

- Patients who progress after discontinuation of lenalidomide treatment are
eligible provided they have not failed rechallenge with lenalidomide

- Eligible to undergo autologous stem cell transplantation (ASCT)

- Meets the requirements for ASCT per Virginia Commonwealth University BMT SOP


- ECOG performance status 0-2

- ANC ≥ 2,000/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 10 g/dL

- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT and/or SGPT ≤ 3 times ULN

- Creatinine clearance ≥ 60 mL/min OR serum creatinine ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use two effective methods of contraception for ≥ 4 weeks
before, during, and for ≥ 4 weeks after completion of study therapy

- Registered in the RevAssist® program AND willing and able to comply with the
requirements of RevAssist®

- Adequate cardiac and pulmonary function for transplant

- No known HIV positivity

- No clinical evidence of uncontrolled viral, fungal, or bacterial infection

- No known or suspected hypersensitivity to azacitidine, mannitol, thalidomide, or

- No other concurrent malignancies

- No other serious medical condition, laboratory abnormality, or psychiatric illness
that would preclude giving informed consent


- See Disease Characteristics

- At least 2 weeks since prior myeloma therapy (other than bisphosphonates)

- Concurrent bisphosphonates allowed

- No other concurrent anticancer agents or treatments

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ability to mobilize and infuse autologous lymphocytes (ALI) after immunomodulatory therapy

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Amir A. Toor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

January 2017

Related Keywords:

  • Multiple Myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Virginia Commonwealth UniversityRichmond, Virginia