Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477783
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-14
Brief Title:
Study on the Clinical Efficacy of Teclistamab
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
TECTONIC
Brief Summary:
The aim of this study is to assess the clinical efficacy and safety of the anti-BCMACD3 bispecific antibody teclistamab Tecvayli in a prospective real-life setting in Belgium
Detailed Description:
To assess the clinical efficacy and safety of teclistamab Tecvayli in relapsedrefractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab Tecvayli as the next treatment Patients will be followed up prospectively until the end of study 24 months2 years or until disease progression withdrawal of consent death or loss to follow-up whichever occurs first Each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab Then data will be collected every 3 months until the end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None