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NCT00675428 · ClinicalTrials.gov registry record · Phase 1
Study of Natalizumab in Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00675428: Clinical Trial Phase 1 study, sponsored by Biogen.
NCT00675428 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00675428, a Phase 1 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.
Primary Outcome
DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) \>3\*upper limit of normal (ULN) with either a total bilirubin \>2\*ULN or an international normalized ratio (INR) \>1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophi
Interventions
- DRUG BG00002 (natalizumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
Why NCT00675428 stopped before completion
NCT00675428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which BG00002 (natalizumab) is the first listed.
NCT00675428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00675428 about?
NCT00675428 is a clinical study titled "Study of Natalizumab in Relapsed/Refractory Multiple Myeloma". The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population...
What is the current status of trial NCT00675428?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2008-09. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00675428?
The interventions under investigation include: BG00002 (natalizumab) (DRUG).
Who is sponsoring clinical trial NCT00675428?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00675428's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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