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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 114 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02616640
The ClinicalTrials.gov registry entry for NCT02616640 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 114 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.
NCT02616640 reports 0 study locations.
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.
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