Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma

Inclusion Criteria:

- Durie-Salmon Stage II or III multiple myeloma

- Newly diagnosed either prior to receiving treatment or having completed induction
therapy

- Relapsed myeloma not previously transplanted within the past 5 years

- Measurable serum and/or urine M-protein from prior to induction therapy documented
and available. A positive serum free lite assay is acceptable

- Age greater than 18 years old

- ECOG performance status of 0 - 2

- Meet all institutional requirements for autologous stem cell transplantation

- The patient must be able to comprehend and have signed the informed consent

Exclusion Criteria:

- Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell
dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein
[M-protein] and skin changes) Non-secretory myeloma (no measurable protein on Serum
Free Lite Assay)

- Plasma cell leukemia

- Amyloidosis

- Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or
bone marrow collection

- Use of any myeloma-specific therapy other than lenalidomide within 21 days of
pre-transplant vaccine

- In a complete remission at the time of bone marrow collection

- Infection requiring treatment with antibiotics, antifungal, or antiviral agents
within seven days of vaccination or bone marrow collection

- Participation in any clinical trial, within four weeks prior to vaccination or bone
marrow collection on this trial, which involved an investigational drug or device

- History of malignancy other than multiple myeloma within five years of vaccination or
bone marrow collection, except adequately treated basal or squamous cell skin cancer

- Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic
lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of
Grave's Disease or Hashimoto's thyroiditis is permitted

- Evidence of spinal cord compression at time of transplant