NCT00897910

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 12, 2013

Completed
Last Updated

January 11, 2016

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

May 9, 2009

Results QC Date

October 22, 2013

Last Update Submit

December 9, 2015

Conditions

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

Location

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.

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Flow CytometryImmunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesImmunoassayImmunologic TechniquesImmunohistochemistryMolecular Probe Techniques

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

  • Zaid Al-Kadhimi, MD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

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

Locations