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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
Sponsor: Janssen Research & Development, LLC
Summary
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.
Official title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2024-08-20
Completion Date
2030-09-02
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Cilta-cel
Cilta-cel infusion will be administered intravenously.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.
Teclistamab
Teclistamab will be administered subcutaneously.
Bortezomib
Bortezomib will be administered subcutaneously as a part of induction.
Lenalidomide
Lenalidomide will be administered orally as a part of induction.
Dexamethasone
Dexamethasone will be administered orally as a part of induction.
Cyclophosphamide
Cyclophosphamide will be administered intravenously as a part of conditioning regimen.
Fludarabine
Fludarabine will be administered intravenously as a part of conditioning regimen.
Locations (16)
City of Hope
Duarte, California, United States
University of California San Francisco
San Francisco, California, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Peter MacCallum Cancer Centre
Melbourne, Australia
The Alfred Hospital
Melbourne, Australia
Instituto D Or de Pesquisa e Ensino
Salvador, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Universitatsklinikum Wurzburg
Würzburg, Germany
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain