T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by Xcyte Therapies.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Xcyte Therapies
ClinicalTrials.gov Identifier:
NCT00048464
First received: October 31, 2002
Last updated: November 6, 2006
Last verified: March 2005
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Procedure: Infusion of Activated & Expanded Autologous T Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Xcellerated T Cells After Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Xcyte Therapies:

Estimated Enrollment: 35
Study Start Date: October 2002
Detailed Description:

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 criteria 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048464

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, San Diego
San Diego, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21231
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Xcyte Therapies
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00048464     History of Changes
Other Study ID Numbers: XT003
Study First Received: October 31, 2002
Last Updated: November 6, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Xcyte Therapies:
Immunotherapy
T Cell Therapy
Peripheral Blood Stem Cell Transplant
Bone marrow transplant
Adoptive immunotherapy
Xcellerate

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014