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A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2023-505792-71-00
Other:
#54767414MMY2093
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A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.

Primary outcome measures

  • Rate of Response with Curative Potential
  • Progression Free Survival (PFS) Rate at 3-Year
  • PFS Rate at 5-Year

Secondary outcome measures

  • Overall response rate (ORR; Partial response [PR] or better)
  • CR or Better Rate
  • Very Good Partial Response (VGPR) or Better Rate
  • Duration of Response (DOR)
  • Time to First Response (TTR)
  • Duration of CR or Better Response
  • Time to First CR or Better Response
  • PFS on next line therapy (PFS2)
  • Overall Survival (OS)
  • MRD-negative CR Rate
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
  • Change from baseline in Health-related quality of life (HRQoL) (symptoms and functioning) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 item instrument (EORTC-QLQ-C30)
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