Multiple Myeloma and Plasma Cell NeoplasmNCT00897910
Studying T Cells in Blood and Bone Marrow Samples From Patients With Multiple Myeloma
An observational study of Multiple Myeloma and Plasma Cell Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- flow cytometry, immunoenzyme technique and laboratory biomarker analysis
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Strategies to Isolate and Expand Myeloma Specific T-cells Using Autologous B Cells as Antigen Presenting Cell B-APC
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.
Read the 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.
- Being tested
- flow cytometry, immunoenzyme technique, laboratory biomarker analysis
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow cytometryOther
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
immunoenzyme techniqueOther
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
laboratory biomarker analysisOther
Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry
Measured: 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
Measured: Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionSep 2012
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute
- Investigators
- Zaid Al-Kadhimi, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897910
- Sponsor's protocol ID
- CDR0000597015
- Other IDs
- P30CA022453, WSU-2007-070
- Status last verified
- Dec 2015
- First submitted
- 9 May 2009
- Last updated
- 11 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Isolate and Expand Myeloma Specific T-cells Using Autologous B Cells as Antigen Presenting Cell B-APC
- ClinicalTrials.gov ID
- NCT00897910
- Acronym / sponsor ID
- CDR0000597015
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 12 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flow cytometryCollection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. | Other | – |
| immunoenzyme techniqueCollection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. | Other | – |
| laboratory biomarker analysisCollection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year. | Other | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaid Al-Kadhimi, MD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Plasma Cell Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.