A Phase III Study of bb2121 CAR T-Cell Therapy Compared to Standard Chemotherapy in People with Recurrent or Persistent Multiple Myeloma

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Full Title

Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)(KarMMa-3)

Purpose

In this study, researchers are comparing the effectiveness of the investigational therapy bb2121 with standard three-drug chemotherapy regimens in people with multiple myeloma that has come back or continued to grow despite treatment. The bb2121 treatment is a type of immunotherapy called CAR T-cell therapy.

During CAR T-cell therapy, a patient’s own T cells (a type of white blood cell) are removed and genetically modified in the laboratory to recognize a protein on their cancer cells (in the case of bb2121, a protein called BCMA). The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancerous cells throughout the body that contain BCMA.

Patients in this study will be randomly assigned to receive bb2121 or a standard three-drug regimen for multiple myeloma. CAR T-cell therapy and some chemotherapies are given by infusion; other chemotherapy drugs for multiple myeloma are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma that came back or continued to grow despite at least two but no more than four prior regimens of treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Sergio Giralt at 212-639-3859.

Protocol

19-321

Phase

III

Investigator

Co-Investigators