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NCT01478048 · ClinicalTrials.gov registry record · Phase 2
Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 185
- Enrollment target
NCT01478048: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01478048 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 185 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478048, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 185 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].
Primary Outcome
PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-comp
Interventions
- DRUG Dexamethasone
- DRUG Bortezomib
- BIOLOGICAL Elotuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2011-11-30 |
| Est. Completion | 2017-04-21 |
| Phase | Phase 2 |
What the finished NCT01478048 record still lists
NCT01478048 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01478048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478048 about?
NCT01478048 is a clinical study titled "Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma". The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].
What is the current status of trial NCT01478048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2011-11-30. Estimated completion is 2017-04-21.
What interventions are being tested in trial NCT01478048?
The interventions under investigation include: Dexamethasone (DRUG), Bortezomib (DRUG), Elotuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01478048?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478048's enrollment target sits among peer trials
185 357th of 2000 higher than 1,641 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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