Xcellerated T CellsTM in Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.

15 patients in each study arm will be followed for 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xcyte Therapies
• Treatments: Fludarabine

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