Clinical trial NCT00897910: Studying T Cells in Blood and Bone Marrow Samples From Patients With Multiple Myeloma
Official title: Strategies to Isolate and Expand Myeloma Specific T-cells Using Autologous B Cells as Antigen Presenting Cell B-APC
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry
timeFrame: Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Secondary outcomes:
measure: Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation
timeFrame: Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Zaid Al-Kadhimi, MD
role: PRINCIPAL_INVESTIGATOR
References: