Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581848
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Korean Post Marketing Surveillance for ELREXFIO Elranatamab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Korean Post Marketing Surveillance for ELREXFIO Elranatamab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to assess the safety and effectiveness of Elranatamab in the real-world clinical settings for the treatment of patients with multiple myeloma in Korea
Detailed Description:
This study is an open-label multi-center non-comparative observational study to assess safety and effectiveness of Elranatamab in the real-world clinical setting in patients with multiple myeloma in Korea
During the study period within 2 years from the launch date a whole case enrollment should be conduct according to the protocol
The objectives of this study are to determine safety and effectiveness with Elranatamab under conditions of general clinical practice in compliance with the regulation of the MFDS Therefore this study was designed according to the PMS guidelines of the MFDS
The study population is patients who are eligible for Indications specified in the approved label
All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this Non-interventional study NIS is being conducted
During the study period within 2 years from the launch date a whole case enrollment should be conduct according to the protocol
The objectives of this study are to determine safety and effectiveness with Elranatamab under conditions of general clinical practice in compliance with the regulation of the MFDS Therefore this study was designed according to the PMS guidelines of the MFDS
The study population is patients who are eligible for Indications specified in the approved label
All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this Non-interventional study NIS is being conducted
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: