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NCT02807454 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
A Phase 2 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02807454 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 37 participants.
The verdict
NCT02807454, a Phase 2 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3). 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 Daratumumab
- DRUG Pomalidomide
- DRUG Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-07-07 |
| Est. Completion | 2022-01-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02807454
The ClinicalTrials.gov registry entry for NCT02807454 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 37 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 4 interventions - of which Dexamethasone is the first listed.
NCT02807454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02807454 about?
NCT02807454 is a clinical study titled "A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma". This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD...
What is the current status of trial NCT02807454?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2016-07-07. Estimated completion is 2022-01-03.
What interventions are being tested in trial NCT02807454?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT02807454?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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