- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04143932
Multiple Myeloma Turkish Prospective Patient Registry (THD-MM-Reg)
July 15, 2023 updated by: Turkish Hematology Association
Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study
This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Omur Gokmen Sevindik, Assoc. Prof.
- Phone Number: +905427870708
- Email: omurgok17@hotmail.com
Study Contact Backup
- Name: Ilker Kurkcu, Pharm
- Phone Number: +905326354515
- Email: ilker.kurkcu@sentez-cro.com
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Medipol University
-
Contact:
- Gokme Sevindik
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
All patients diagnosed as multiple myeloma received maximum 2 lines of therapy will be included to this prospective registry.
Description
Inclusion Criteria:
- Diagnosed as multiple myeloma
- Patients signed informed consent form
- Patients received no more then 2 lines of therapy
Exclusion Criteria:
- Patients below 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: [Time Frame: 5 Years]
|
Time from the diagnosis to the death
|
[Time Frame: 5 Years]
|
|
Progression Free Survival
Time Frame: [Time Frame: 5 Years]
|
Time from the initiation of treatment to the death from any cause or progression
|
[Time Frame: 5 Years]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Omur Gokmen Sevindik, Assoc. Prof., Medipol University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2020
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 27, 2019
First Submitted That Met QC Criteria
October 27, 2019
First Posted (Actual)
October 30, 2019
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 15, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- THD-MM-Reg
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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