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NCT00911859 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT00911859: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT00911859 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00911859, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).
Primary Outcome
CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, \<5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.
Interventions
- DRUG Melphalan
- DRUG Siltuximab11 mg/kg
- DRUG Siltuximab 8.3 mg/kg or 11 mg/kg
- DRUG Velcade (bortezomib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00911859 record still lists
NCT00911859 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 4 interventions - of which Melphalan is the first listed.
NCT00911859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00911859 about?
NCT00911859 is a clinical study titled "A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients". The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).
What is the current status of trial NCT00911859?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2009-06. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00911859?
The interventions under investigation include: Melphalan (DRUG), Siltuximab11 mg/kg (DRUG), Siltuximab 8.3 mg/kg or 11 mg/kg (DRUG), Velcade (bortezomib) (DRUG).
Who is sponsoring clinical trial NCT00911859?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00911859's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 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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