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NCT02254551 · ClinicalTrials.gov registry record · Phase 2
Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
A Phase 2 study, sponsored by SCRI Development Innovations.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT02254551: Clinical Trial Phase 2 study, sponsored by SCRI Development Innovations.
NCT02254551 is a Phase 2 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02254551, a Phase 2 study, was terminated before completion, sponsored by SCRI Development Innovations.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether the combination of LDE225 (sonidegib) plus bortezomib is safe and effective in the treatment of relapsed or relapsed/refractory multiple myeloma.
Primary Outcome
During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.
Interventions
- DRUG Bortezomib
- DRUG LDE225
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
Why NCT02254551 stopped before completion
NCT02254551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Bortezomib is the first listed.
NCT02254551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02254551 about?
NCT02254551 is a clinical study titled "Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma". The purpose of the study is to determine whether the combination of LDE225 (sonidegib) plus bortezomib is safe and effective in the treatment of relapsed or relapsed/refractory multiple myeloma.
What is the current status of trial NCT02254551?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2015-01. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02254551?
The interventions under investigation include: Bortezomib (DRUG), LDE225 (DRUG).
Who is sponsoring clinical trial NCT02254551?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02254551's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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