Clinical Trial

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Study acronym: GEM-TECTAL
Active, Not Recruiting Phase 2
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Summary
The goal of this Phase 2, open-label, multicenter, non-randomized pilot study is to evaluate the efficacy (in terms of MRD negative CR rate after Intensification therapy) and safety of Tec-Dara (Teclistamab+Daratumumab) and Tal-Dara (Talquetamab+Daratumumab) in de novo high-risk multiple myeloma (DNHRMM) patients.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-04-27; most recent amendment 2026-05-06.
Status change: Recruiting → Active, Not Recruiting 2025-03-14
Status change: Not Yet Recruiting → Recruiting 2023-09-05
Trial Details
NCT Number NCT05849610
Lead Sponsor PETHEMA Foundation
Collaborators: Janssen Pharmaceutica N.V., Belgium
Conditions High-Risk de Novo Multiple Myeloma
Enrollment 30 participants
Start Date 2023-09-21
Primary Completion 2026-03-03 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-11