At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 86 enrolled
Drug / intervention
Cilta-cel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Cilta-cel and Lymphodepleting Therapy (Cyclophosphamide and Fludarabine) for Multiple Myeloma. Completed, enrolled 86 participants across 18 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartMay 2022
Primary CompletionNov 2023
Study CompletionDec 2023
TodayJul 2026
First PostedApr 26, 2022
Enrollment StartMay 13, 2022
Primary CompletionNov 30, 2023
Study CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.2 years ago
Interventions
Cilta-celdrug
Cilta-cel will be administered as an IV infusion.
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)drug
Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.