A Phase III Study Comparing JNJ-68284528 CAR T-Cell Therapy with a Combination of Standard Medical Treatments in Patients with Recurrent or Persistent Multiple Myeloma

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Full Title

A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, vs Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4) (WIRB)

Purpose

CAR T-cell therapy is a type of immunotherapy. 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. The modified T cells are multiplied in the lab and returned to the patient to find and destroy cancer cells. 

In this study, researchers are evaluating the effectiveness of a new CAR T-cell therapy called JNJ-68284528 (Cilta-cel) in patients with multiple myeloma that has come back or continued to grow despite initial treatment. JNJ-68284528 recognizes a protein on most multiple myeloma cells called BCMA. 

Patients in this study will be randomly assigned to receive either JNJ-68284528 or one of these combinations of medications that are already used to treat multiple myeloma: pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

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 one to three prior regimens of therapy that included an immunomodulatory drug (such as lenalidomide) and a proteasome inhibitor.
  • Patients may not have previously received CAR T-cell therapy or any treatment that targets BCMA.
  • Patients should recover from the side effects of previous therapies before receiving the study treatment.
  • Patients must have measurable disease (as demonstrated by any one of the following: serum M protein of 1 g/dL or more, urine M protein of at least 200 mg/24 hours, or involved free light chain of 10 mg/dL or more).
  • 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
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Urvi Shah at 646-608-3713 or 212-639-7016.

Protocol

21-033

Phase

III

Investigator

Co-Investigators