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

Fecha de inicio: 1 de noviembre de 2003

* 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