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NCT01335399 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 748
- Enrollment target
NCT01335399: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01335399 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 748 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335399, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 748 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
Primary Outcome
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the l
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 748 participants |
| Start Date | 2011-08-04 |
| Est. Completion | 2021-09-03 |
| Phase | Phase 3 |
What the finished NCT01335399 record still lists
NCT01335399 is an interventional study that assigns participants to a tested intervention. The registered 748 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01335399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335399 about?
NCT01335399 is a clinical study titled "Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma". The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
What is the current status of trial NCT01335399?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 748 participants. The study started on 2011-08-04. Estimated completion is 2021-09-03.
What interventions are being tested in trial NCT01335399?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01335399?
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 NCT01335399's enrollment target sits among peer trials
748 472nd of 2000 higher than 1,529 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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