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NCT02951819 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma
A Phase 2 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT02951819: Completed Phase 2 study, sponsored by Janssen Scientific Affairs.
NCT02951819 is a Phase 2 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02951819, a Phase 2 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.
Primary Outcome
Percentage of participants who achieved CR or VGPR (as per International Myeloma Working Group \[IMWG\] criteria) was reported. CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percent (%) plasma cells (PC) in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (\>=) 90% reduction in serum M-protein plus urine M-protein level \< 100 milligram per
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2016-11-09 |
| Est. Completion | 2020-08-17 |
| Phase | Phase 2 |
What the finished NCT02951819 record still lists
NCT02951819 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02951819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02951819 about?
NCT02951819 is a clinical study titled "A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma". The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed su...
What is the current status of trial NCT02951819?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2016-11-09. Estimated completion is 2020-08-17.
What interventions are being tested in trial NCT02951819?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT02951819?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02951819's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 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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