The PHASE3 study NCT05083169, investigating Teclistamab in combination with Daratumumab subcutaneously (SC) for participants with Relapsed or Refractory Multiple Myeloma, reached its primary completion date on 2025-09-15. This trial compares the combination of Teclistamab and Daratumumab against standard regimens.
Background
This study focuses on Multiple Myeloma, a cancer of plasma cells. Teclistamab is being investigated for its efficacy in treating this condition.
Trial design
The PHASE3 study, identified as NCT05083169, enrolled 587 participants with Relapsed or Refractory Multiple Myeloma. The study's purpose is to compare the efficacy of Teclistamab in combination with Daratumumab subcutaneously (SC) (Tec-Dara) against two comparator arms: Daratumumab SC in combination with Pomalidomide and Dexamethasone (DPd), or Daratumumab SC in combination with Bortezomib and Dexamethasone (DVd).
What this means
The primary completion of the PHASE3 study NCT05083169 indicates that the final data collection for the primary outcome measure has concluded. The next steps will involve data analysis to evaluate the efficacy of Teclistamab in combination with Daratumumab for participants with Relapsed or Refractory Multiple Myeloma compared to the specified control regimens. Results from this study will be crucial for understanding the potential role of this combination therapy.
Source
This information was sourced from ClinicalTrials.gov, documenting the primary completion of trial NCT05083169, which occurred on 2025-09-15. The study details are available on clinicaltrials.gov.