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Status:

COMPLETED

Xcellerated T CellsTM in Patients With Multiple Myeloma

Lead Sponsor:

Xcyte Therapies

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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 w...

Detailed Description

This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma. Subjects mu...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    June 1 2004

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00078065

    Start Date

    November 1 2003

    End Date

    June 1 2004

    Last Update

    November 11 2005

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Oncotherapeutics

    Los Angeles, California, United States, 90067

    2

    University of California, San Diego

    San Diego, California, United States, 92093

    3

    University of California, San Francisco

    San Francisco, California, United States, 94143

    4

    Johns Hopkins Medical Institute

    Baltimore, Maryland, United States, 21231