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NCT00402181 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 2 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT00402181: Completed Phase 2 study, sponsored by Centocor.
NCT00402181 is a Phase 2 study that has completed, run by Centocor. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00402181, a Phase 2 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of siltuximab in participants with relapsed (the return of a disease or the signs and symptoms of a disease after a period of improvement.) or refractory (cancer that does not respond to treatment) multiple myeloma (a type of cancer that begins in plasma cells \[white blood cells that produce antibodies\]).
Primary Outcome
The overall response is defined as percentage of participants having confirmed Complete Response (CR) and Partial Response (PR) by using the European Group for Blood and Marrow Transplantation (EBMT) criteria. CR is absence of the original monoclonal protein (M-protein) in serum and urine maintained for a minimum of 6 weeks, and disappearance of soft tissue plasmacytomas. PR is greater than or equal to (\>=) 50 percent reduction in the level of the serum M-protein maintained for a minimum of 6 w
Interventions
- DRUG Dexamethasone
- BIOLOGICAL Siltuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00402181 record still lists
NCT00402181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00402181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00402181 about?
NCT00402181 is a clinical study titled "An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma". The purpose of this study is to evaluate the safety and efficacy of siltuximab in participants with relapsed (the return of a disease or the signs and symptoms of a disease after a period of improvement.) or refractory (cancer that does not respond to treatment) multiple myeloma (a type of cancer th...
What is the current status of trial NCT00402181?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2006-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00402181?
The interventions under investigation include: Dexamethasone (DRUG), Siltuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00402181?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402181's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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