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THD-MM-Reg: Multiple Myeloma Turkish Prospective Patient Registry

Sponsor
Turkish Hematology Association (Other)
Overall Status
Recruiting
CT.gov ID
NCT04143932
Collaborator
(none)
1,000
Enrollment
1
Location
49.7
Anticipated Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study
    Actual Study Start Date :
    Oct 10, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [[Time Frame: 5 Years]]

      Time from the diagnosis to the death

    2. Progression Free Survival [[Time Frame: 5 Years]]

      Time from the initiation of treatment to the death from any cause or progression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medipol University Istanbul Turkey

    Sponsors and Collaborators

    • Turkish Hematology Association

    Investigators

    • Principal Investigator: Omur Gokmen Sevindik, Assoc. Prof., Medipol University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turkish Hematology Association
    ClinicalTrials.gov Identifier:
    NCT04143932
    Other Study ID Numbers:
    • THD-MM-Reg
    First Posted:
    Oct 30, 2019
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Turkish Hematology Association
    multiple myeloma
    MM
    Registry
    Turkey
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Oct 5, 2021