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

Terminated

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm

• Registration Number: NCT00897910
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2009-11
• Study Completion: 2012-09
• Results First Submitted: 2013-10-22
• Results First Submitted QC: 2013-10-22
• Results First Posted: 2013-12-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States