Multiple MyelomaNCT01820546
Cancer Stem Cells in Multiple Myeloma
An observational study of Multiple Myeloma, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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: New Diagnosed or Relapsed Multiple Myeloma Patients
Who may be able to join
- New Diagnosed or Relapsed Multiple Myeloma
- Routine Bone Marrow Aspiration will be done
Who cannot join
- Bone Marrow Aspiration is not Needed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Hematology Unit
Ankara, 06590
About this study
Official title: Flow Cytometric Definition and Prognostic Effects of Multiple Myeloma Cancer Stem Cells
In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.
Read the detailed description
The investigators' hypothesis is that, multiple myeloma plasma cells derivate from principal cells that is called "cancer or progenitor stem cell". In multiple myeloma to define immunophenotyping features of these "cancer stem cells" with flow cytometry and to show their prognostic value and check for any relationship between cancer stem cell quantification and chemotherapy response are main aims of this study.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response
After 3 courses chemotherapy treatment response
Measured: 3 months
Secondary outcomes (1)
Treatment Response
After 6 courses chemotherapy treatment response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ozen, Ankara University
- Investigators
- Mehmet Ozen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820546
- Sponsor's protocol ID
- TR06
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2013
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsui W, Huff CA, Wang Q, Malehorn MT, Barber J, Tanhehco Y, Smith BD, Civin CI, Jones RJ. Characterization of clonogenic multiple myeloma cells. Blood. 2004 Mar 15;103(6):2332-6. doi: 10.1182/blood-2003-09-3064. Epub 2003 Nov 20.
PubMed 14630803
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometric Definition and Prognostic Effects of Multiple Myeloma Cancer Stem Cells
- ClinicalTrials.gov ID
- NCT01820546
- Acronym / sponsor ID
- TR06
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.
Detailed description
The investigators' hypothesis is that, multiple myeloma plasma cells derivate from principal cells that is called "cancer or progenitor stem cell". In multiple myeloma to define immunophenotyping features of these "cancer stem cells" with flow cytometry and to show their prognostic value and check for any relationship between cancer stem cell quantification and chemotherapy response are main aims of this study.
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
- New Diagnosed or Relapsed Multiple Myeloma Patients
Key inclusion criteria (2 listed)
- New Diagnosed or Relapsed Multiple Myeloma
- Routine Bone Marrow Aspiration will be done
Key exclusion criteria (1 listed)
- Bone Marrow Aspiration is not Needed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Response
Time frame: 3 months
After 3 courses chemotherapy treatment response
1 secondary outcome
Treatment Response
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Background: PubMed 14630803Matsui W, Huff CA, Wang Q, Malehorn MT, Barber J, Tanhehco Y, Smith BD, Civin CI, Jones RJ. Characterization of clonogenic multiple myeloma cells. Blood. 2004 Mar 15;103(6):2332-6. doi: 10.1182/blood-2003-09-3064. Epub 2003 Nov 20.
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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.
Mehmet Ozen, MD principal investigator
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, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 6 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820546, which also lists 1 linked publication.
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 6 Jan 2016.