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Home > "A" Clinical Trials Conditions > Autologous T Cell Immunotherapy With or Without Fludarabine in Treating Patients With Relapsed or Refractory Multiple Myeloma  Autologous T Cell Immunotherapy With or Without Fludarabine in Treating Patients With Relapsed or Refractory Multiple Myeloma
Autologous T Cell Immunotherapy With or Without Fludarabine in Treating Patients With Relapsed or Refractory Multiple Myeloma
For Condition: refractory plasma cell neoplasm
Status: Recruiting
Sponsor(s): Xcyte Therapies ,
Synopsis: RATIONALE: Immunotherapy using a person's own T cells that have been treated in the laboratory may cause a stronger immune response to kill cancer cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining fludarabine with autologous T-cell immunotherapy may kill more cancer cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of autologous T-cell immunotherapy with or without fludarabine in treating patients who have relapsed or refractorymultiple myeloma.
Details: OBJECTIVES: Primary - Compare changes in serum M-protein levels in patients with relapsed or refractory multiple myeloma treated with autologous Xcellerated T Cellsâ„¢ with or without fludarabine. Secondary - Compare response rates (complete, very good partial, partial, minimal, and overall) in patients treated with these regimens. - Compare safety of these regimens in these patients. - Compare antitumor immune responses in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. All patients undergo leukapheresis. The T cells are then expanded ex vivo using the Xcellerateâ„¢ process. - Arm I: Patients receive autologous Xcellerated T Cellsâ„¢ IV on day 0. - Arm II: Patients receive fludarabine IV over 30 minutes on days -8 to -4 and autologous Xcellerated T Cellsâ„¢ as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma - Failed at least 1, but no more than 4, prior cytotoxic therapies - Induction therapy followed by chemotherapy and autologous hematopoietic stem cell transplantation (HSCT) is considered 1 prior therapy - Relapsed or progressive disease after most recent therapy - No relapse or disease progression within 1 year of prior HSCT - Measurable serum and/or urine M-protein - No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) - No non-secretory myeloma - No plasma cell leukemia - No amyloidosis - No spinal cord compression PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin at least 10.0 g/dL (transfusions or epoetin alfa allowed) - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count greater than 75,000/mm^3 Hepatic - Hepatitis B negative* - Hepatitis C negative* - Bilirubin no greater than 2.0 times upper limit of normal (ULN) - ALT no greater than 2.0 times ULN - No hepatic dysfunction that would preclude study participation NOTE: *Determined by antibody, antigen, or nucleic acid tests Renal - Creatinine no greater than 2.5 mg/dL - Calcium less than 11 mg/dL - No evidence of symptomatic hypercalcemia - No renal dysfunction that would preclude study participation Cardiovascular - No New York Heart Association class III or IV heart disease Pulmonary - No pulmonary disease requiring inhaled steroids or bronchodilators Immunologic - No prior allergy to mice or murine (mouse) proteins - No autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, or systemic lupus erythematosus) requiring systemic treatment - Human anti-mouse antibody undetectable or normal - HIV-1 and -2 negative - Human T-cell lymphotrophic virus-1 and -2 negative Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No gastrointestinal dysfunction that would preclude study participation - No neurological dysfunction that would preclude study participation - No other medical or psychological condition that would preclude study participation - Hypothyroidism allowed provided there is no evidence of Graves' disease or Hashimoto's thyroiditis PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 14 days since prior thalidomide - No concurrent thalidomide - No concurrent interferon - No concurrent growth factors or cytokines (except filgrastim [G-CSF] or epoetin alfa) - No concurrent interleukins Chemotherapy - See Disease Characteristics Endocrine therapy - More than 14 days since prior glucocorticoids (e.g., dexamethasone) - No concurrent systemic corticosteroids Radiotherapy - More than 28 days since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 14 days since prior bortezomib - More than 14 days since prior systemic therapy for multiple myeloma (except bisphosphonates) - More than 7 days since prior antibiotics, antifungals, or antivirals for infection - More than 4 weeks since prior clinical trial participation - No concurrent bortezomib - No other concurrent cytotoxic agents - No other concurrent experimental therapies - No concurrent immunosuppressive therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkFrohlich, Study Chair, Xcyte Therapies
Oncotherapeutics *Recruiting*
Los Angeles, California, 90067
United States
Recruiting James Berenson 310-407-0439
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0690
United States
Recruiting Asad Bashey 858-657-6790
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Ravi Vij 314-454-8304
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Ivan Borrello 410-955-4967
Additional Information:
Study ID Numbers: CDR0000339612; XCYTE-XT005,XCYTE-SPR-08-0019
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072371
Other Refractory Plasma Cell Neoplasm Studies:
1. 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
2. Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
3. PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Autologous T Cell Immunotherapy With or Without Fludarabine in Treating Patients With Relapsed or Refractory Multiple Myeloma
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