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NCT02685826 · ClinicalTrials.gov registry record · Phase 1
A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT02685826 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 56 participants.
The verdict
NCT02685826, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone (dex) in adults with newly diagnosed multiple myeloma (NDMM). The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to determine the optimal regimen. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. The decision by the FDA was based on data from non-Celgene-sponsored studies related to risks of anti-programmed cell death 1 (PD-1), pembrolizumab, in combination with immunomodulatory agents. As the result, the study was closed for further enrollment, and all subjects were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All subjects are being followed for second primary malignancies (SPMs), every 6 months for 5 years after the last subject has been enrolled as per protocol. After stopping data collection in the clinical database, any SPM events will continue to be recorded in the subject's source documents, and reported to Celgene Drug Safety.
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2016-04-25 |
| Est. Completion | 2022-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02685826
The ClinicalTrials.gov registry entry for NCT02685826 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02685826 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02685826 about?
NCT02685826 is a clinical study titled "A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma". This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone (dex) in adults with newly diagnosed multiple myeloma (NDMM). The study will consist of a dose-finding phase as well a...
What is the current status of trial NCT02685826?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2016-04-25. Estimated completion is 2022-09-06.
What interventions are being tested in trial NCT02685826?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT02685826?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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