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Home > "X" Clinical Trials Conditions > Xcellerated T CellsTM in Patients with Multiple Myeloma  Xcellerated T CellsTM in Patients with Multiple Myeloma
Xcellerated T CellsTM in Patients with Multiple Myeloma
For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): Xcyte Therapies ,
Synopsis: 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.
Details: 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 must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation. Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients will be followed for six months following treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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 withone 1 year following autologous hematopoietic stem cell transplantation. Repeat courses of the same therapueutic 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
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
MarkFrohlich, Study Chair, Xcyte Therapies
Oregon Health Sciences University *Not yet recruiting*
Portland, Oregon, 97239
United States
Not yet recruiting Aubyn Grant 503-494-5074
Johns Hopkins Medical Institute *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Beena George 410-614-4838
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Alisa Ruddell 314-454-5095
Florida Cancer Specialists *Not yet recruiting*
Ft. Myers, Florida, 33901
United States
Not yet recruiting Colleen Faulkner 239-947-3092
Cancer Centers of the Carolinas *Not yet recruiting*
Greenville, South Carolina, 29605
United States
Not yet recruiting Sebrina Madden 864-679-3967
University of California, San Diego *Recruiting*
San Diego, California, 92093
United States
Recruiting Vineeta Prasad 858-657-7028
Hackensack University Medical Center *Not yet recruiting*
Hackensack, New Jersey, 07601
United States
Not yet recruiting Arianne Vliet 201-996-5804
Rocky Mountain Cancer Centers *Not yet recruiting*
Denver, Colorado, 80218
United States
Not yet recruiting Juli Murphy 303-285-5087
University of Southern California *Not yet recruiting*
Los Angeles, California, 90033
United States
Not yet recruiting Bryon Espina 323-865-0371
Center for Cancer & Blood Disorders *Not yet recruiting*
Bethesda, Maryland, 20817
United States
Not yet recruiting Natalie Bongiorno 301-571-0019
Oncotherapeutics *Recruiting*
Los Angeles, California, 90067
United States
Recruiting Regina Swift 323-525-1105
University of California, San Francisco *Recruiting*
San Francisco, California, 94143
United States
Recruiting Michael Thomas 415-476-3741
Additional Information:
Study ID Numbers: XT005;
Study Start Date: November 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078065
Other Multiple Myeloma Studies:
1. Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
2. An Open Protocol for the Compassionate Use of Thalidomide for Patients with Advanced or Refractory Malignancies
3. Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma
4. PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
5. Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Xcellerated T CellsTM in Patients with Multiple Myeloma
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