search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Infusion of Activated & Expanded Autologous T Cells
Sponsored by
Xcyte Therapies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Immunotherapy, T Cell Therapy, Peripheral Blood Stem Cell Transplant, Bone marrow transplant, Adoptive immunotherapy, Xcellerate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center
  • University of California, San Diego
  • University of California, San Francisco
  • Johns Hopkins Medical Institute
  • Washington University
  • Hackensack University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 31, 2002
Last Updated
November 6, 2006
Sponsor
Xcyte Therapies
search

1. Study Identification

Unique Protocol Identification Number
NCT00048464
Brief Title
T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
Official Title
A Phase I/II Study of Xcellerated T Cells After Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Xcyte Therapies

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Immunotherapy, T Cell Therapy, Peripheral Blood Stem Cell Transplant, Bone marrow transplant, Adoptive immunotherapy, Xcellerate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Infusion of Activated & Expanded Autologous T Cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Johns Hopkins Medical Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11786906
Citation
Levine BL, Bernstein WB, Aronson NE, Schlienger K, Cotte J, Perfetto S, Humphries MJ, Ratto-Kim S, Birx DL, Steffens C, Landay A, Carroll RG, June CH. Adoptive transfer of costimulated CD4+ T cells induces expansion of peripheral T cells and decreased CCR5 expression in HIV infection. Nat Med. 2002 Jan;8(1):47-53. doi: 10.1038/nm0102-47.
Results Reference
background
PubMed Identifier
11777267
Citation
Thomas AK, June CH. The promise of T-lymphocyte immunotherapy for the treatment of malignant disease. Cancer J. 2001 Nov-Dec;7 Suppl 2:S67-75.
Results Reference
background
PubMed Identifier
11696694
Citation
June CH. Can't get any help? New approaches for adoptive immunotherapy of cancer. J Immunother. 2001 Sep-Oct;24(5):389-91. No abstract available.
Results Reference
background
Citation
Frohlich, M., Grosmaire, L., Xu, J., Rasmussen, A., Roehrs, H., Lindgren, R., Ferrand, C., Tiberghien, P., Leis, J., and Bonyhadi, ML: Xcellerate: a novel autologous T cell immunotherapeutic approach for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). The IX International Workshop on CLL.2002.
Results Reference
background
PubMed Identifier
12142553
Citation
Li Q, Yu B, Grover AC, Zeng X, Chang AE. Therapeutic effects of tumor reactive CD4+ cells generated from tumor-primed lymph nodes using anti-CD3/anti-CD28 monoclonal antibodies. J Immunother. 2002 Jul-Aug;25(4):304-13. doi: 10.1097/00002371-200207000-00002.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs