A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
Public ClinicalTrials.gov record NCT03000452. 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
MEDI4736-MM-005 (FUSION MM-005): A Phase 2, Multicenter, Single-Arm, Study to Determine the Efficacy for the Combination of Durvalumab (DURVA) Plus Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) That Have Progressed While on Current Treatment Regimen Containing Daratumumab.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly \[QW\], every 2 weeks \[Q2W\] or every 4 weeks \[Q4W\] of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.
Study identification
- NCT ID
- NCT03000452
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 18 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
- Mar 14, 2017 (Actual)
- Primary completion
- Sep 18, 2017 (Actual)
- Completion
- Dec 4, 2017 (Actual)
- Last update posted
- Oct 16, 2018
2017
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Cancer Center | Duarte | California | 91010-300 | — |
| Cancer Center of Central Connecticut | Southington | Connecticut | 06489 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-528 | — |
| University of Kansas Hospital | Westwood | Kansas | 66205 | — |
| University of Maryland School of Med | Baltimore | Maryland | 21201-1595 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Memorial Hosp | Morristown | New Jersey | 07962 | — |
| OHSU | Portland | Oregon | 97201 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03000452, 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 Oct 16, 2018 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03000452 live on ClinicalTrials.gov.