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NCT02903381 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02903381: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT02903381 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02903381, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This research study is evaluating a new drug called "nivolumab" as a possible treatment for smoldering multiple myeloma in order to prevent or postpone development of active multiple myeloma. \- Patients with smoldering multiple myeloma do not have symptoms but are at risk for progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment.
Primary Outcome
The primary endpoint will be the 2-year progression-free percent and will be reported with corresponding 90% confidence interval. All patients who have received one dose of study treatment will be included for the analysis, including those who die or are lost to follow-up before 2 years. Progression is defined as ≥ 25% increase and an absolute increase of ≥ 0.5g/dL from their nadir in their serum or urine m-spike or FLC with no CRAB features attributable to MM progression.
Interventions
- DRUG Nivolumab
- DRUG Dexamethasone
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-10-20 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 2 |
What the finished NCT02903381 record still lists
NCT02903381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT02903381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02903381 about?
NCT02903381 is a clinical study titled "A Phase II Trial If Nivolumab, Lenalidomide and Dexamethasone in High Risk Smoldering Myeloma". This research study is evaluating a new drug called "nivolumab" as a possible treatment for smoldering multiple myeloma in order to prevent or postpone development of active multiple myeloma. \- Patients with smoldering multiple myeloma do not have symptoms but are at risk for progressing to active...
What is the current status of trial NCT02903381?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2016-10-20. Estimated completion is 2021-09-16.
What interventions are being tested in trial NCT02903381?
The interventions under investigation include: Nivolumab (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT02903381?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02903381's enrollment target sits among peer trials
8 1990th 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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