Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479954
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
ELREXFIO SPECIAL INVESTIGATION- INVESTIGATION ON LONG-TERM TREATMENT -
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use
Detailed Description:
The objective of this study is to assess the safety and efficacy in patients with relapsed and refractory multiple myeloma RRMM treated with elranatamab under the actual use
Primary objective Confirm whether the onset status the number of patients incidence grade seriousness timing of onset duration treatment and outcome of cytokine release syndrome CRS and immune effector cell-associated neurotoxicity syndrome ICANS is comparable to that in the clinical studies and whether adverse reactions were appropriately treated
Secondary objective Confirm the onset status of any adverse reaction including unknown adverse reaction to long-term treatment with elranatamab and the overall response ORR as efficacy assessment and evaluate them in terms of benefit-risk
Conditions for approval Because of the extremely limited number of patients treated in Japanese clinical studies a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab early collect data on the safety and efficacy of elranatamab and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated
Primary objective Confirm whether the onset status the number of patients incidence grade seriousness timing of onset duration treatment and outcome of cytokine release syndrome CRS and immune effector cell-associated neurotoxicity syndrome ICANS is comparable to that in the clinical studies and whether adverse reactions were appropriately treated
Secondary objective Confirm the onset status of any adverse reaction including unknown adverse reaction to long-term treatment with elranatamab and the overall response ORR as efficacy assessment and evaluate them in terms of benefit-risk
Conditions for approval Because of the extremely limited number of patients treated in Japanese clinical studies a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab early collect data on the safety and efficacy of elranatamab and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated
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?: