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NCT03000452 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT03000452: Completed Phase 2 study, sponsored by Celgene.
NCT03000452 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03000452, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Objective response is defined as a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the investigator assessment: sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but no
Interventions
- DRUG DARATUMUMAB
- DRUG DURVALUMAB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2017-12-04 |
| Phase | Phase 2 |
What the finished NCT03000452 record still lists
NCT03000452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which DARATUMUMAB is the first listed.
NCT03000452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03000452 about?
NCT03000452 is a clinical study titled "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)". 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...
What is the current status of trial NCT03000452?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2017-03-14. Estimated completion is 2017-12-04.
What interventions are being tested in trial NCT03000452?
The interventions under investigation include: DARATUMUMAB (DRUG), DURVALUMAB (DRUG).
Who is sponsoring clinical trial NCT03000452?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03000452's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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