Phase I/II Clinical Trial Combining hTERT Tumor Vaccine & Autologous T Cells in Patients With Advanced Myeloma

Each subject must meet ALL of the following criteria during screening to be enrolled in the study:

1. Written informed consent must be obtained from all patients before entry into the study
2. Patients must have a diagnosis of myeloma
3. Patients must meet one of the following criteria:

   * Myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy.
   * Myeloma has responded partially to initial therapy but neither a complete nor a near-complete response has developed after at least 3 cycles or months of initial therapy.
   * Myeloma has high-risk features
4. Patients must have measurable disease on study entry.
5. Patients must be between ages 18-80 (inclusive).
6. Patients should have adequate vital organ function.
7. ECOG performance status 0-2
8. Women of child-bearing potential (WOCBP) and their spouses or partners must be willing to use adequate contraception for the duration of the active treatment phase of the study and for at least 4 months after the last dose of chemotherapy. In addition, contraceptive measures must be continued as long as the patient remains on maintenance thalidomide in accordance with the STEPS program.

Key Exclusion Criteria

Subjects who meet ANY of the following criteria cannot be enrolled in the study:

1. Pregnant or nursing females
2. HIV, HTLV-1/2 seropositivity
3. Known history of myelodysplasia
4. Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
5. Active Hepatitis B
6. Prior autotransplant or allogeneic transplant
7. More than 4 distinct, prior courses of therapy for myeloma
8. History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
9. Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
10. Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which might increase the risks of participating in the study
11. Active bacterial, viral or fungal infections.