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NCT00401843 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 307
- Enrollment target
- 20
- Study locations
NCT00401843: Completed Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT00401843 is a Phase 2 study of Multiple Myeloma that has completed, run by Janssen Research & Development. The registered enrollment target is 307 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00401843, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 307 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.
Primary Outcome
Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response \[CR\]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune rec
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Bortezomib
- BIOLOGICAL Siltuximab
Study Locations (20)
Other
- - Antwerp
- - B-8000 Brugge
- - Brussels
- - Edegem
- - Leuven
- - Rio de Janeiro
- - Bulgaria
- - Pleven
- - Plovdiv
California
- - Greenbrae
- - Los Angeles
New York
- - New York
- - Syracuse
Texas
- - Dallas
- - Houston
Indiana
- - Indianapolis
New Mexico
- - Albuquerque
North Carolina
- - Chapel Hill
South Carolina
- - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2006-11-28 |
| Est. Completion | 2019-09-24 |
| Phase | Phase 2 |
What the finished NCT00401843 record still lists
NCT00401843 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00401843 names 20 study sites across 9 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT00401843 about?
NCT00401843 is a clinical study titled "A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma". The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortez...
What is the current status of trial NCT00401843?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 307 participants. The study started on 2006-11-28. Estimated completion is 2019-09-24.
What conditions does trial NCT00401843 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT00401843?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Siltuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00401843?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00401843 being conducted?
This trial has 20 study locations across California, Indiana, New Mexico, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00401843's enrollment target sits among peer trials
307 72nd of 438 higher than 367 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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