drugset / Trial / NCT05572229
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
Phase 2
Recruiting
74 enrolled
University Hospital, Lille
Janssen Pharmaceutica N.V., Belgium · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | — | Subcutaneous |
| Subject | Lenalidomide | Other / unclassified | — | Oral |
| Subject | Teclistamab | Monoclonal antibody | — | Subcutaneous |