Study Stopped
Funding unavailable
Studying T Cells in Blood and Bone Marrow Samples From Patients With Multiple Myeloma
Strategies to Isolate and Expand Myeloma Specific T-cells Using Autologous B Cells as Antigen Presenting Cell B-APC
3 other identifiers
observational
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
December 12, 2013
CompletedJanuary 11, 2016
December 1, 2015
1.6 years
May 9, 2009
October 22, 2013
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Eligibility Criteria
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Biospecimen
Data from flow cytometry, and Cytokine release assays for B cells and T cells from peripheral blood mononuclear cells (PBMCs) will be obtained.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Tis study was closed due to technical laboratory difficulty in performing the experiments proposed.
Results Point of Contact
- Title
- Zaid S. Al-Kadhimi, M.D.
- Organization
- Barbara Ann Karmanos Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Zaid Al-Kadhimi, MD
Barbara Ann Karmanos Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
April 1, 2008
Primary Completion
November 1, 2009
Study Completion
September 1, 2012
Last Updated
January 11, 2016
Results First Posted
December 12, 2013
Record last verified: 2015-12