A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma

Inclusion Criteria

- Previous diagnosis of multiple myeloma (MM) based on standard criteria. Tests need
not be performed within 30 days of registration.

- Failure of at least one, but no more than four, prior systemic therapies for MM prior
to registration and may not have relapsed or progressed within 1 year following
autologous hematopoietic stem cell transplantation. Repeat courses of the same
therapeutic regimen separated in time by 6 or more months are considered separate
therapies. Induction therapy followed by high dose chemotherapy and autologous
hematopoietic stem cell transplantation counts as one therapy.

- Measurable serum and/or urine M-protein

- Disease progression or relapse, since most recent therapy for multiple myeloma

- Age > 18 years old and < 75 years old

- ECOG performance status of 0 or 1

- Females of child-bearing potential must have a negative serum bHCG test and be
willing to use effective contraception (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the trial

- Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2,
hepatitis B, and hepatitis C within 30 days of registration (Antibody, antigen, and
nucleic acid tests acceptable, depending on institutional standards)

- Hemoglobin >= 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is
permissible.

- White blood count (WBC) >= 3,000/mm3 and absolute neutrophil count (ANC) > 1000/mm3

- Platelet count > 75,000/mm3

- Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia.
(Corrected serum calcium is calculated by adding 0.8 mg/dL to the measured serum
calcium for every 1 g/dL that the serum albumin falls below 4.0 g/dL)

- Serum total bilirubin and alanine aminotransferase (ALT) < 2.0 times the upper limit
of normal

- Serum creatinine < 2.5 mg/dL

- Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range,
and no history of allergies to mice or murine (mouse) proteins

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