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

• Sponsor: Barbara Ann Karmanos Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00897910
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 6
• Location: 1
• Duration (Months): 53
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Other: flow cytometry; Other: immunoenzyme technique; Other: laboratory biomarker analysis

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 Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• 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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Sep 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zaid Al-Kadhimi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
• ClinicalTrials.gov Identifier: NCT00897910
• Other Study ID Numbers: CDR0000597015; P30CA022453; WSU-2007-070
• First Posted: May 12, 2009
• Last Update Posted: Jan 11, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Zaid Al-Kadhimi, Principal Investigator, Barbara Ann Karmanos Cancer Institute: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the outpatient clinics or inpatient service of Karmanos Cancer Center by physicians in the Department of Hematology and Medical Oncology, between April 2008 and October 2009.
Pre-assignment Detail	All 6 consented subjects had blood drawn during their routine labs. No bone marrow samples were collected.

Arm/Group Title	Collection of Circulating Blood and Bone Marrow.
Arm/Group Description
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Collection of Circulating Blood and Bone Marrow.
Arm/Group Description
Overall Participants	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (0)
Sex: Female, Male (Count of Participants)
Female	2 33.3%
Male	4 66.7%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Collection of Blood and Bone Marrow.
Arm/Group Description
Measure Participants	0

2. Secondary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Collection of Circulating Blood and Bone Marrow.
Arm/Group Description
All Cause Mortality
	Collection of Circulating Blood and Bone Marrow.
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Collection of Circulating Blood and Bone Marrow.
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Collection of Circulating Blood and Bone Marrow.
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Tis study was closed due to technical laboratory difficulty in performing the experiments proposed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.