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NCT05347485 · ClinicalTrials.gov registry record · Phase 2
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
A Phase 2 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT05347485: Completed Phase 2 study, sponsored by Janssen Scientific Affairs.
NCT05347485 is a Phase 2 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05347485, a Phase 2 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Primary Outcome
ORR is defined as the percentage of participants who had partial response (PR) or better (sCR+CR+VGPR+PR) according to the International Myeloma Working Group (IMWG) response criteria, as assessed by the investigator. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells (PCs) in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or i
Interventions
- DRUG Cilta-cel
- DRUG Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-05-13 |
| Est. Completion | 2023-12-15 |
| Phase | Phase 2 |
What the finished NCT05347485 record still lists
NCT05347485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Cilta-cel is the first listed.
NCT05347485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05347485 about?
NCT05347485 is a clinical study titled "A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma". The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
What is the current status of trial NCT05347485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2022-05-13. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT05347485?
The interventions under investigation include: Cilta-cel (DRUG), Lymphodepleting Therapy (Cyclophosphamide and Fludarabine) (DRUG).
Who is sponsoring clinical trial NCT05347485?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05347485's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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