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NCT02616640 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
NCT02616640: Completed Phase 1 study, sponsored by Celgene.
NCT02616640 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 114 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02616640, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen. On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.
Primary Outcome
Number of participants with DLTs in the first cycle of treatment
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2016-01-11 |
| Est. Completion | 2024-07-30 |
| Phase | Phase 1 |
What the finished NCT02616640 record still lists
NCT02616640 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02616640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02616640 about?
NCT02616640 is a clinical study titled "A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma". This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion por...
What is the current status of trial NCT02616640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2016-01-11. Estimated completion is 2024-07-30.
What interventions are being tested in trial NCT02616640?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT02616640?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02616640's enrollment target sits among peer trials
114 507th of 2000 higher than 1,493 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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