Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505369
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study Measuring MRD Negativity After Bispecific T-cell Redirectors Talquetamab and Teclistamab Consolidation in Sequence as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2024-07
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:
TALTEC
Brief Summary:
This is Phase 2 open-label multicentre non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth increase MRD negative CR rate
Detailed Description:
A total of 50 transplant-eligible patients with newly diagnosed multiple myeloma in need of treatment will be enrolled
The study consists of three phases Induction Consolidation and Follow-up Induction will consist of Dara-VRd and consolidation Part I will include talquetamab and Part II will include teclistamab
Follow-up Phase After consolidation treatment continues upon physicians choice the options are ASCT with maintenance or only maintenance with lenalidomide
Efficacy will be evaluated by serumurine electrophoresis monthly by serumurine immunofixation bone marrow morphology and flow cytometry when CRsCR is suspected
MRD will be evaluated by NGS at the level of 10-6 and FDG PET-CT by Deauville score at various timepoints during induction consolidation and follow-up
Participants quality of life symptoms functional and general well-being will be captured using 3 PRO measures PRO-CTCAE EORTC QLQ-C30 FACT-Cog
The safety of study drugs will be assessed by physical examinations vital signs ECGs clinical laboratory tests neurologic examinations including ICE scores ECOG performance status and AE monitoring according to NCI-CTCAE Version 50 grading of CRS and ICANS will be assessed based on ASTCT guidelines
The study consists of three phases Induction Consolidation and Follow-up Induction will consist of Dara-VRd and consolidation Part I will include talquetamab and Part II will include teclistamab
Follow-up Phase After consolidation treatment continues upon physicians choice the options are ASCT with maintenance or only maintenance with lenalidomide
Efficacy will be evaluated by serumurine electrophoresis monthly by serumurine immunofixation bone marrow morphology and flow cytometry when CRsCR is suspected
MRD will be evaluated by NGS at the level of 10-6 and FDG PET-CT by Deauville score at various timepoints during induction consolidation and follow-up
Participants quality of life symptoms functional and general well-being will be captured using 3 PRO measures PRO-CTCAE EORTC QLQ-C30 FACT-Cog
The safety of study drugs will be assessed by physical examinations vital signs ECGs clinical laboratory tests neurologic examinations including ICE scores ECOG performance status and AE monitoring according to NCI-CTCAE Version 50 grading of CRS and ICANS will be assessed based on ASTCT guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None