aMMbition

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

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
40
Last Updated
1 week ago
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Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Bortezomib Bortezomib is a kind of medication called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body. Bortezomib is used to treat multiple myeloma and mantle cell lymphoma.
  • Ciltacabtagene Autoleucel (cilta-cel) is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express the B-cell maturation antigen (BCMA).
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
  • Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Lenalidomide is an oral immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.
  • Talquetamab is a bispecific antibody that binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells. 
  • Teclistamab is a bispecific antibody that targets BCMA, which is expressed in mature B lymphocytes, and CD3, which is expressed on T-cells.

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