A randomized phase 3 trial comparing Teclistamab monotherapy with pomalidomide, bortezomib, dexamethasone (PVd), or carfilzomib, dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including a monoclonal antibody anti-CD38 and lenalidomid
Project objectivesThe primary objective of this study is to compare the efficacy of teclistamab monotherapy (arm A) with that of investigator-chosen PVd or Kd (arm B: hereafter referred to as PVd/Kd) as assessed by PFS. Key secondary objectives include efficacy comparisons assessed by proportion of participants achieving complete response or better, MRD negativity, OS, and time to worsening in MySIm-Q total symptom score. |
Start and end date |
| 09th June 2023 |
Project Manager |
| Ombretta Annibali - Principal Investigator |
Coordinating institution of the project |
| AoU Policlinico sant'Orsola Malpighi - dr. Michele cable |
Other Institutions involved |
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Funding source(s). |
| • Janssen Research & Development, LLC |
