drugset / Trial / NCT05767359

CAR- PRISM (PRecision Intervention Smoldering Myeloma)

NCT05767359

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy)

Timeline

Start
2023-04-19
Primary completion
2025-12-15
Completion
2040-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject ciltacabtagene autoleucel Cell therapy 300000 cells/kg Intravenous
Subject ciltacabtagene autoleucel Cell therapy 500000 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous