While treatment options for multiple myeloma (MM) are continuing to expand, this disease remains one characterized by requiring multiple lines of therapy, with generally decreasing effectiveness of each subsequent line. The development of B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy has proven an exception to this rule. In the trial that led to approval of the BCMA CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel) by the U.S. Food and Drug Administration (FDA), deep and durable response rates were observed in heavily pretreated patients. In this review we summarize the available clinical trial data for cilta-cel, including discussion on notable adverse events, as well as discuss ongoing studies that are likely to lead to paradigm changes in the management of MM. In addition, we discuss the issues that currently surround the real-world utilization of cilta-cel.
Keyphrases
- cell therapy
- multiple myeloma
- drug administration
- clinical trial
- stem cells
- mesenchymal stem cells
- end stage renal disease
- ejection fraction
- study protocol
- chronic kidney disease
- randomized controlled trial
- systematic review
- phase iii
- phase ii
- prognostic factors
- electronic health record
- patient reported outcomes
- risk assessment
- case control
- human health
- deep learning
- replacement therapy