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NCT01239797 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 646
- Enrollment target
NCT01239797: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01239797 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 646 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239797, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 646 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
Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomizat
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Dexamethasone (Oral)
- DRUG Dexamethasone (IV)
- BIOLOGICAL Elotuzumab (BMS-901608; HuLuc63)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2011-06-20 |
| Est. Completion | 2021-04-21 |
| Phase | Phase 3 |
What the finished NCT01239797 record still lists
NCT01239797 is an interventional study that assigns participants to a tested intervention. The registered 646 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT01239797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01239797 about?
NCT01239797 is a clinical study titled "Phase III Study of Lenalidomide 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 Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
What is the current status of trial NCT01239797?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 646 participants. The study started on 2011-06-20. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT01239797?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Dexamethasone (Oral) (DRUG), Dexamethasone (IV) (DRUG), Elotuzumab (BMS-901608; HuLuc63) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01239797?
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 NCT01239797's enrollment target sits among peer trials
646 572nd of 2000 higher than 1,429 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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