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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 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03000452
The ClinicalTrials.gov registry entry for NCT03000452 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 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 2 interventions - of which DARATUMUMAB is the first listed.
NCT03000452 reports 0 study locations.
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.
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