Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05297240
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-03-17
Brief Title:
Retrospective Study of the Use of Belantamab Mafodotin Blenrep in Patients With Relapsed andor Refractory Multiple Myeloma RRMM in Spain
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
Retrospective Study of the Use of Belantamab Mafodotin Blenrep in Patients With Relapsed andor Refractory Multiple Myeloma RRMM in Spain
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021
The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate ORR duration of response DOR progression free survival PFS overall survival OS and the safety of single agent belantamab mafodotin in patients with RRMM
Subjects may receive treatment until progression Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group IMWG criteria from cycle 1 day 1 until confirmed progressive disease death unacceptable toxicity or lost to follow-up whichever occurs first
The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate ORR duration of response DOR progression free survival PFS overall survival OS and the safety of single agent belantamab mafodotin in patients with RRMM
Subjects may receive treatment until progression Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group IMWG criteria from cycle 1 day 1 until confirmed progressive disease death unacceptable toxicity or lost to follow-up whichever occurs first
Detailed Description:
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021
Subjects may receive treatment until progression Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group IMWG criteria from cycle 1 day 1 until confirmed progressive disease death unacceptable toxicity or lost to follow-up whichever occurs first
The study has the following objectives
Primary objective
- The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response and the different response categories when administered as a single agent in patients with RRMM
Secondary objectives
Describe the safety and tolerability of single-agent belantamab mafodotin
The overall incidence of ophthalmologic complications
Estimate duration of response DOR
Estimate time to response TTR
Estimate time to next treatment TTNT
Estimate progression-free survival PFS and overall survival OS
Type of treatment administered after single-agent belantamab mafodotin and estimate PFS2
Subjects may receive treatment until progression Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group IMWG criteria from cycle 1 day 1 until confirmed progressive disease death unacceptable toxicity or lost to follow-up whichever occurs first
The study has the following objectives
Primary objective
- The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response and the different response categories when administered as a single agent in patients with RRMM
Secondary objectives
Describe the safety and tolerability of single-agent belantamab mafodotin
The overall incidence of ophthalmologic complications
Estimate duration of response DOR
Estimate time to response TTR
Estimate time to next treatment TTNT
Estimate progression-free survival PFS and overall survival OS
Type of treatment administered after single-agent belantamab mafodotin and estimate PFS2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None