drugset / Trial / NCT05849610

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

NCT05849610 ↗

Phase 2 Active not recruiting 30 enrolled PETHEMA Foundation Janssen Pharmaceutica N.V., Belgium · collab
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2023-09-21
Primary completion
2026-03-03
Completion
2029-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — Subcutaneous
Subject Daratumumab Monoclonal antibody — Subcutaneous
Subject Lenalidomide Other / unclassified — Oral
Subject Talquetamab Monoclonal antibody — Subcutaneous
Subject Teclistamab Monoclonal antibody — Subcutaneous

Indications

No indication recorded.