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

NCT ID: NCT00897910

Last Updated: 2016-01-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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flow cytometry

Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.

Intervention Type OTHER

immunoenzyme technique

Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.

Intervention Type OTHER

laboratory biomarker analysis

Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Zaid Al-Kadhimi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zaid Al-Kadhimi, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

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Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2007-070

Identifier Type: -

Identifier Source: secondary_id

CDR0000597015

Identifier Type: -

Identifier Source: org_study_id

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