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T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant Clinical research trials and T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant. T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant clinical trial. Test subjects typically obtain the finest healthcare available for their T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant  T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): Xcyte Therapies ,
Synopsis: Patients will have immune cells collected and then expanded outside of the body. Patients will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem cell transplantation. Three days following the transplant, patients will receive an infusion of a large number of expanded immune cells. The goal of the study will be to determine the safety as well as potential efficacy of this treatment
Details: This Phase I/II clinical study is designed to examine the safety of Xcellerated T Cells, an activated, autologous T cell product, in study subjects undergoing an autologous peripheral blood stem cell transplant for the treatment of multiple myeloma. Thirty-five patients will be treated. Patients must have undergone induction therapy prior to study registration, and may not have progressed following induction therapy or any other prior therapy for myeloma. Patients will undergo a steady state leukapheresis (Xcellerate Leukapheresis) to obtain peripheral blood mononuclear cells that will be used to produce Xcellerated T Cells. During the Xcellerate Process, T cells will be activated and expanded ex vivo by co-stimulation with anti-CD3 and anti-CD28 monoclonal antibodies covalently attached to super-paramagnetic microbeads. While the Xcellerated T Cells are being produced at Xcyte Therapies, patients will be treated with a standard mobilization regimen consisting of cyclophosphamide and filgrastim (Neupogen; G-CSF), followed by a second leukapheresis for collection of peripheral blood stem cells. Patients will be treated with a standard high-dose chemotherapy regimen for multiple myeloma consisting of single agent melphalan (200mg/m2). Patients will then receive their peripheral blood stem cells followed by post-transplant filgrastim for neutrophil recovery. Three days (Day 3) following stem cell infusion, patients will receive a single dose Xcellerated T Cells.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Patient Inclusion Criteria - Previous diagnosis of multiple myeloma based on standard criteria. Tests need not be performed within 30 days of registration. - Durie-Salmon Stage II or III disease at any time since diagnosis - Induction therapy with a minimum of 3 cycles of chemotherapy or 3 months of high-dose corticosteroids without progressive disease. (Note: no glucocorticoids are allowed within 3 weeks of registration; see exclusion criteria.) - Measurable serum and/or urine M-protein from prior to induction therapy documented and available - Lymphocyte subsets by flow cytometry demonstrating CD3+ >= 10% of the peripheral white blood cell count, and CD4+/CD8+ >= 0.30. Test must be obtained following completion of induction therapy. - Meets all institutional critieria for and has institutional approval to undergo autologous peripheral blood stem cell transplantation - Age >= 18 years old and <=70 years old - ECOG performance status of 0 or 1 - Life expectancy > 6 months - 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, or condom with spermicide, or abstinence) up to Day 180. - Negative test results for current/active infection with HIV-1, HIV-2, hepatitis B, and hepatitis C within 60 days of registration.(Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards.) - 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 SGPT (ALT) < 2.0 times the upper limit of normal - Serum creatinine < 2.0 mg/dL - No detectable human anti-mouse antibody (HAMA) titer, and no history of allergies to mice or murine (mouse) proteins - The patient must be able to comprehend and have signed the informed consent Patient Exclusion Criteria - Diagnosis of any of the following cancers: -POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes) -Non-secretory myeloma -Plasma cell leukemia - Diagnosis of amyloidosis - Progression or relapse presently or in the past, during or following therapy for multiple myeloma - Previous hematopoietic stem cell transplantation - Use of corticosteroids (glucocorticoids) within 21 days of registration - Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration - Participation in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug or device - History of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancer. Any other exceptions must be discussed with Xcyte Therapies’ Medical Monitor prior to registration. - History of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of Grave’s Disease or Hashimoto’s thyroiditis is permitted. - Evidence of spinal cord compression - Major organ system dysfunction including (but not limited to): New York Heart Association Class III or IV, pulmonary disease requiring the use of inhaled steroids or bronchodilators, renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction which would impair patient’s ability to participate in the trial
Total Enrollment: 35
Location and Contact Information:
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, San Diego
San Diego, California, 92093
United States
Hackensack University
Hackensack, New Jersey, 07601
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Washington University
St. Louis, Missouri, 63110
United States
Johns Hopkins Medical Institute
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: XT003;
Study Start Date: October 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048464
Other Multiple Myeloma Studies:
1. Combination Bisphosphonate and Anti-Angiogenesis Therapy with Pamidronate and Thalidomide
2. Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome
3. CDC-501 therapy in relapsed or refractory multiple myeloma
4. Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma
5. Safety and pharmacokinetics of orally administered gallium maltolate in various refractory malignancies.
Related Studies:
Other Multiple Myeloma Clinical Trials
Other New Jersey Clinical Trials
Other Hackensack Clinical Trials
T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
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