drugset / Trial / NCT05572229

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

NCT05572229

Non-randomizedSequentialOpen-labelTreatment

Summary

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.

Timeline

Start
2023-12-21
Primary completion
2026-04
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody Subcutaneous
Subject Lenalidomide Other / unclassified Oral
Subject Teclistamab Monoclonal antibody Subcutaneous

Indications