Multiple Myeloma Turkish Prospective Patient Registry | NCT04143932

Studies
Multiple Myeloma Turkish Prospective Patient Registry

NCT04143932

Sponsor

Turkish Hematology Association

Status

Unknown status

Last Update Posted

Jul 18, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Multiple Myeloma
Relapse Multiple Myeloma

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2020Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Oct 27, 2019

First Submission Date that Met QC Criteria

Oct 27, 2019

First Posted Date

Oct 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2023

Last Update Posted Date

Jul 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Time from the diagnosis to the death	[Time Frame: 5 Years]
Progression Free Survival	Time from the initiation of treatment to the death from any cause or progression	[Time Frame: 5 Years]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients diagnosed as multiple myeloma received maximum 2 lines of therapy will be included to this prospective registry.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omur Gokmen Sevindik, Assoc. Prof.	Contact	+905427870708		omurgok17@hotmail.com
Ilker Kurkcu, Pharm	Contact	+905326354515		ilker.kurkcu@sentez-cro.com

Overall Officials

Name	Affiliation	Role
Omur Gokmen Sevindik, Assoc. Prof.	Medipol University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medipol University	Recruiting	Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided