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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Other: flow cytometry
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Enrollment 6
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 Details 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.
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 6 [1]
Completed 6 [2]
Not Completed 0
[1]
None of the blood samples were analyzed due to lack of funding. No tissue sample was collected.
[2]
None of the blood samples were analyzed due to lack of funding. No tissue sample was collected
Arm/Group Title Collection of Circulating Blood and Bone Marrow.
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
53  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry
Hide Description [Not Specified]
Time Frame Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Collection of Blood and Bone Marrow.
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation
Hide Description [Not Specified]
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 Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Collection of Circulating Blood and Bone Marrow.
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Collection of Circulating Blood and Bone Marrow.
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Collection of Circulating Blood and Bone Marrow.
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Collection of Circulating Blood and Bone Marrow.
Affected / at Risk (%)
Total   0/0 
Tis study was closed due to technical laboratory difficulty in performing the experiments proposed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Zaid S. Al-Kadhimi, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8022
Responsible Party: Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00897910     History of Changes
Other Study ID Numbers: CDR0000597015
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-070
First Submitted: May 9, 2009
First Posted: May 12, 2009
Results First Submitted: October 22, 2013
Results First Posted: December 12, 2013
Last Update Posted: January 11, 2016