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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2007-070 |
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Funding unavailable
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about T cells and plan better treatment for multiple myeloma.
PURPOSE: This research study is looking at T cells in blood and bone marrow samples from patients with multiple myeloma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Peripheral blood and bone marrow samples are collected periodically for laboratory studies. Samples are analyzed to assess the feasibility of expanding autologous B cells ex vivo using CD40L and IL-4; the antigen-presenting phenotype of autologous B-cell antigen-presenting cells (B-APCs) using flow cytometry; and the antigen-presenting function of B-APCs using ELISPOT and chromium-release assay. Myeloma-specific interferon γ secreting T cells are isolated and selected using Miltenyi beads. The selected myeloma-specific T cells are expanded ex vivo using anti CD3/CD28 beads.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flow cytometry | Other | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. | ||
| immunoenzyme technique | Other | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. | ||
| laboratory biomarker analysis | Other | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. |
| Measure | Description | Time Frame |
|---|---|---|
| Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients with a diagnosis of multiple myeloma identified from the outpatient clinics or inpatient service of Karmanos Cancer Center by physicians in the Department of Hematology and Medical Oncology.
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| Name | Affiliation | Role |
|---|---|---|
| Zaid Al-Kadhimi, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
All 6 consented subjects had blood drawn during their routine labs. No bone marrow samples were collected.
Subjects were recruited from the outpatient clinics or inpatient service of Karmanos Cancer Center by physicians in the Department of Hematology and Medical Oncology, between April 2008 and October 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Collection of Circulating Blood and Bone Marrow. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Collection of Circulating Blood and Bone Marrow. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry | Posted | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collection of Circulating Blood and Bone Marrow. |
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Tis study was closed due to technical laboratory difficulty in performing the experiments proposed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zaid S. Al-Kadhimi, M.D. | Barbara Ann Karmanos Cancer Institute | 313-576-8022 | alkadhiz@karmanos.org |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| D007124 | Immunoenzyme Techniques |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Data from flow cytometry, and Cytokine release assays for B cells and T cells from peripheral blood mononuclear cells (PBMCs) will be obtained.
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation | Not Posted | Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. |
| 0 |
| 0 |
| 0 |
| 0 |
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| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |