iMMagine-3

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

What's the purpose of the trial?

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival (PFS) per blinded independent review committee (IRC).
Trial status

Accepting patients

Phase
Phase 3
Enrollment
450
Last Updated
1 month ago
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Participating Centers

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Experimental Treatments

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  • Anitocabtagene Autoleucel is a BCMA directed CAR T cell therapy in development for multiple myeloma.
  • 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.
  • Carfilzomib Carfilzomib is a kind of medication called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body. Carfilzomib is used in the treatment of multiple myeloma. 
  • 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.
  • Pomalidomide is a kind of medication called an immunomodulatory agent that promotes an immune response to help slow tumor growth. Pomalidomide is used in the treatment of several different indications.

Arms / Cohorts

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Accepting patients

Anitocabtagene Autoleucel

Accepting patients

Standard of Care Therapy (SOCT)

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