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

This study has suspended participant recruitment.
(Insufficient staff)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00897910
First received: May 9, 2009
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Multiple Myeloma and Plasma Cell Neoplasm
 Other: flow cytometry
Other: immunoenzyme technique
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Strategies to Isolate and Expand Myeloma Specific T-cells Using Autologous B Cells as Antigen Presenting Cell B-APC

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Data from flow cytometry, and Cytokine release assays for B cells and T cells from peripheral blood mononuclear cells (PBMCs) will be obtained.


Estimated Enrollment: 15
Study Start Date: April 2008
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: flow cytometry
    Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
    Other: immunoenzyme technique
    Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
    Other: laboratory biomarker analysis
    Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897910

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Zaid Al-Kadhimi, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00897910     History of Changes
Other Study ID Numbers: CDR0000597015, P30CA022453, WSU-2007-070
Study First Received: May 9, 2009
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013