Studying T Cells in Blood and Bone Marrow Samples From Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Strategies to Isolate and Expand Myeloma Specific T-cells Using Autologous B Cells as Antigen Presenting Cell B-APC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00897910
• Other study ID #: CDR0000597015
• Secondary ID: P30CA022453WSU-2
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: December 9, 2015
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: December 2015
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Other:
• flow cytometry
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
• immunoenzyme technique
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
• laboratory biomarker analysis
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No