Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Brief summary
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.
Detailed description
OBJECTIVES: Primary * To evaluate the feasibility of expanding myeloma-specific T cells using autologous ex vivo expanded B cells loaded with myeloma antigens as antigen-presenting cells (B-APCs) in peripheral blood and bone marrow samples from patients with multiple myeloma. Secondary * To examine the feasibility of selecting and expanding myeloma-specific T cells ex vivo using interferon γ release and CD3/CD28 stimulation. 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.
Interventions
OTHERflow cytometry
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
OTHERimmunoenzyme technique
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
OTHERlaboratory biomarker analysis
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All 6 consented subjects had blood drawn during their routine labs. No bone marrow samples were collected.
Participants by arm
| Arm | Count |
|---|---|
| Collection of Circulating Blood and Bone Marrow. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Collection of Circulating Blood and Bone Marrow. |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry
Time frame: Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Secondary
Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation
Time frame: Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.