Treated T Cells Followed by a Stem Cell Transplant in Treating Patients With Multiple Myeloma
NCT ID: NCT00938626
Last Updated: 2013-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2009-10-31
2013-03-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best way to give treated T cells followed by stem cell transplant in treating patients with multiple myeloma.
Detailed Description
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Primary
* To test the feasibility and safety of infusing anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells (CD20Bi-AATC) before stem cell mobilization and collection for autologous peripheral blood stem cell transplantation (PBSCT) in patients with multiple myeloma.
Secondary
* To explore functional changes in immune cell populations as a consequence of immunotherapy to test the hypothesis that CD20Bi-AATC can induce anti-clonogenic myeloma precursor cell (CMPC) effect as measured by cytotoxicity; serum cytokine levels; and serum antibody titers to myeloma cells pre-immunotherapy, after immunotherapy, and after high-dose chemotherapy and autologous PBSCT.
* To explore whether the infusion of CD20Bi-AATC reduces the proportion of plasma cells with the CD20+ CMPC phenotype in patients' bone marrow as assessed by multi-color flow cytometry before and after immunotherapy.
* To assess the proportion of bone marrow colony-forming assays before induction or salvage chemotherapy, pre-immunotherapy, and post-immunotherapy to determine whether the infusion grossly affects the bone marrow progenitor populations.
* To explore whether infusions of CD20Bi-AATC induce a B-cell defect causing an immunoglobulin deficiency after autologous PBSCT.
* To measure immunoglobulin deficiency after autologous PBSCT (e.g., quantitative IgG, IgM, and IgA levels and number of circulating T- and B-cell subsets).
OUTLINE: After completion of induction or salvage chemotherapy, patients receive immunotherapy comprising anti-CD3 x anti-CD20-armed ATC IV weekly for 2 weeks. At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.
Blood samples are collected periodically to evaluate antibody titers to recall antigens; serum IgG, IgM, and IgA levels; the proportion of circulating B-cells by phenotyping for CD19, CD20, CD22, CD23, CD4, CD8, and CD38; the ability of peripheral blood mononuclear cells to kill multiple myeloma cell lines or the patient's own cryopreserved myeloma cells via cytotoxicity assays and ELISPOT assays; and human anti-mouse antibody responses to murine IgG2a (OKT3). Bone marrow biopsies are also collected to analyze the phenotype of cells (CD20+, CD138-, CD27+, CD22, etc.) via flow cytometry and the proportion of plasma cells via flow cytometry and hematoxylin-and-eosin staining.
After completion of study treatment, patients are followed up for up to 1 year.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Armed-activated T cells/Immunotherapy
At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.
anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells
After completion of induction or salvage chemotherapy, patients receive immunotherapy comprising anti-CD3 x anti-CD20-armed ATC IV weekly for 2 weeks.
autologous hematopoietic stem cell transplantation
At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.
peripheral blood stem cell transplantation
At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation.
Interventions
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anti-CD3 x anti-CD20 bispecific antibody-armed activated T cells
After completion of induction or salvage chemotherapy, patients receive immunotherapy comprising anti-CD3 x anti-CD20-armed ATC IV weekly for 2 weeks.
autologous hematopoietic stem cell transplantation
At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis for G-CSF-mobilized autologous T-cells.
peripheral blood stem cell transplantation
At least 1-3 weeks after the second infusion, patients receive high-dose chemotherapy and then undergo autologous peripheral blood stem cell transplantation.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of multiple myeloma
* Candidate for high-dose chemotherapy and autologous stem cell transplantation
* No definite morphologic evidence of myelodysplasia on pretreatment bone marrow
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 or Karnofsky PS 70-100%
* ANC \> 500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Total bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 3 times upper limit of normal
* Creatinine ≤ 2.0 mg/dL
* LVEF ≥ 45%
* Corrected pulmonary diffusion capacity ≥ 50%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infections or other severe medical problems such as adrenal dysfunction
* No other active malignancy (except for nonmelanoma skin cancer) that requires myelosuppressive chemotherapy or radiotherapy
* No HIV infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* On-chemotherapy induction with thalidomide or lenalidomide with dexamethasone is allowed
* No prior stem cell transplantation
* No more than 2 prior treatment regimens (including the one during which patients undergo leukapheresis for T-cells)
* No more than 4 courses of lenalidomide in combination with other agents or as a single agent over a 1-year period
* No other concurrent immunotherapy, radiotherapy, chemotherapy, or anti-myeloma therapy at the time of the anti-CD3 x anti-CD20-armed ATC infusion
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Jeffrey Zonder
Principal Investigator
Principal Investigators
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Jeffrey A. Zonder, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Other Identifiers
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WSU-2008-106
Identifier Type: -
Identifier Source: secondary_id
CDR0000646891
Identifier Type: -
Identifier Source: org_study_id