Multiple MyelomaTHD-MM-RegNCT04143932
Multiple Myeloma Turkish Prospective Patient Registry
An observational study of Multiple Myeloma and Relapse Multiple Myeloma, run by Turkish Hematology Association at 1 site in Turkey (Türkiye).
Trial summary
This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapse Multiple Myeloma
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2020to Dec 2024
- How long will I take part?
- 3 Years
- 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: All patients diagnosed as multiple myeloma received maximum 2 lines of therapy will be included to this prospective registry.
Who may be able to join
- Diagnosed as multiple myeloma
- Patients signed informed consent form
- Patients received no more then 2 lines of therapy
Who cannot join
- Patients below 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol University
Istanbul
Gokme Sevindik
About this study
Official title: Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study
This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey
Read the detailed description
In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end.
All the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.
- Conditions
- Multiple Myeloma, Relapse Multiple Myeloma
- Keywords
- multiple myeloma, MM, Registry, Turkey
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from the diagnosis to the death
Measured: [Time Frame: 5 Years]
Progression Free Survival
Time from the initiation of treatment to the death from any cause or progression
Measured: [Time Frame: 5 Years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start10 Oct 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Turkish Hematology Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omur Gokmen Sevindik, Assoc. Prof., Principal investigator, Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143932
- Sponsor's protocol ID
- THD-MM-Reg
- Acronym
- THD-MM-Reg
- Status last verified
- Jul 2023
- First submitted
- 27 Oct 2019
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study
- ClinicalTrials.gov ID
- NCT04143932
- Acronym / sponsor ID
- THD-MM-Reg / THD-MM-Reg
- Conditions
- Multiple Myeloma, Relapse Multiple Myeloma
- Keywords
- multiple myeloma, MM, Registry, Turkey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Turkish Hematology AssociationUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Oct 2019 (actual)
- 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.
This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey
Detailed description
In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end.
All the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed as multiple myeloma received maximum 2 lines of therapy will be included to this prospective registry.
Key inclusion criteria (3 listed)
- Diagnosed as multiple myeloma
- Patients signed informed consent form
- Patients received no more then 2 lines of therapy
Key exclusion criteria (1 listed)
- Patients below 18 years old
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
Overall Survival
Time frame: [Time Frame: 5 Years]
Time from the diagnosis to the death
Progression Free Survival
Time frame: [Time Frame: 5 Years]
Time from the initiation of treatment to the death from any cause or progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
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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.
Omur Gokmen Sevindik, Assoc. Prof. principal investigator
Medipol University Hospital
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 Relapse Multiple Myeloma, run by Turkish Hematology Association 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 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omur Gokmen Sevindik, Assoc. Prof. (+905427870708, omurgok17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: [Time Frame: 5 Years]). The study lists 2 primary outcomes in all. 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 18 Jul 2023.