Skip to content

TALTEC: A phase II study measuring MRD negativity after bispecific T-cell redirectors TALquetamab and TEClistamab consolidation as part of first line treatment in transplant eligible multiple myeloma patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508212-38-00
Acronym
TALTEC JNJ-54767414
Enrollment
50
Registered
2024-03-26
Start date
2024-06-11
Completion date
Unknown
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of talquetamab and 6 cycles of teclistamab consolidation therapy

Detailed description

MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of Dara-VRd induction, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of talquetamab, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of teclistamab, Proportion of participants with persistent MRD negative disease at month 12 and 24 after completing treatment with teclistamab, by NGS (sensitivity level of 10-6), and FDG PET-CT scan, Overall Response Rate (ORR), Overall Survival (OS), Progression free survival (PFS), Duration of response (DOR), Time to next anti-myeloma treatment (TTNT), TEAEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0), Incidence of participant-recorded side effects (during the treatment with talquetamab and teclistamab) Impact of treatment on (physical, social, cognitive, emotional, overall) quality of life, MRD status 100 days after starting of standard of care treatment

Interventions

DRUGDARZALEX 1800 mg solution for injection
DRUGDEXAMETHASONE
DRUGteclistamab
DRUGLENALIDOMIDE
DRUGBORTEZOMIB

Sponsors

North Estonia Medical Centre Foundation
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of talquetamab and 6 cycles of teclistamab consolidation therapy

Secondary

MeasureTime frame
MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of Dara-VRd induction, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of talquetamab, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of teclistamab, Proportion of participants with persistent MRD negative disease at month 12 and 24 after completing treatment with teclistamab, by NGS (sensitivity level of 10-6), and FDG PET-CT scan, Overall Response Rate (ORR), Overall Survival (OS), Progression free survival (PFS), Duration of response (DOR), Time to next anti-myeloma treatment (TTNT), TEAEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0), Incidence of participant-recorded side effects (during the treatment with talquetamab and t

Countries

Denmark, Estonia, Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026