A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
Public ClinicalTrials.gov record NCT02807454. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02807454
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 37 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2016
- Primary completion
- Jan 2, 2022
- Completion
- Jan 2, 2022
- Last update posted
- Feb 20, 2023
2016 – 2022
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| UCLA Division of Hematology Oncology | Los Angeles | California | 90095-1752 | — |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | — |
| Local Institution - 007 | Denver | Colorado | 80218 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Dana-Farber Partners Cancer Care, Inc. | Boston | Massachusetts | 02115 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania - Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology Nashville Drug Development Unit | Nashville | Tennessee | 37203 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02807454, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2023 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02807454 live on ClinicalTrials.gov.