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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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
6.00

PATIENT CHARACTERISTICS:

- 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
lenalidomide

- No other concurrent malignancies

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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

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

- Concurrent bisphosphonates allowed

- No other concurrent anticancer agents or treatments