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NCT01393964 · ClinicalTrials.gov registry record · Phase 1
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01393964: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01393964 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393964, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.
Primary Outcome
The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured i
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- BIOLOGICAL Elotuzumab (BMS-901608; HuLuc63)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-01-06 |
| Est. Completion | 2016-07-18 |
| Phase | Phase 1 |
What the finished NCT01393964 record still lists
NCT01393964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01393964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01393964 about?
NCT01393964 is a clinical study titled "Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function". The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.
What is the current status of trial NCT01393964?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2012-01-06. Estimated completion is 2016-07-18.
What interventions are being tested in trial NCT01393964?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Elotuzumab (BMS-901608; HuLuc63) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01393964?
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 NCT01393964's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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