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Trial record 30 of 2555 for:    "Plasma Cell Neoplasm"

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

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ClinicalTrials.gov Identifier: NCT00897910
Recruitment Status : Terminated (Funding unavailable)
First Posted : May 12, 2009
Results First Posted : December 12, 2013
Last Update Posted : January 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Results First Submitted Date October 22, 2013
Results First Posted Date December 12, 2013
Last Update Posted Date January 11, 2016
Study Start Date April 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2011)
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. ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry
Change History Complete list of historical versions of study NCT00897910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 2, 2011)
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. ]
Original Secondary Outcome Measures
 (submitted: May 9, 2009)
Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Data from flow cytometry, and Cytokine release assays for B cells and T cells from peripheral blood mononuclear cells (PBMCs) will be obtained.
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.
Condition Multiple Myeloma and Plasma Cell Neoplasm
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 22, 2013)
6
Original Estimated Enrollment
 (submitted: May 9, 2009)
15
Actual Study Completion Date September 2012
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00897910
Other Study ID Numbers CDR0000597015
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute
Study Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Zaid Al-Kadhimi, MD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date December 2015