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NCT02136134 · ClinicalTrials.gov registry record · Phase 3
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 498
- Enrollment target
NCT02136134: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02136134 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 498 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02136134, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 498 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
Primary Outcome
PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (\>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be \>=0.5 gram per deciliter (g/dL); Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24
Interventions
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG VELCADE (Bortezomib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2014-08-15 |
| Est. Completion | 2024-01-10 |
| Phase | Phase 3 |
What the finished NCT02136134 record still lists
NCT02136134 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02136134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02136134 about?
NCT02136134 is a clinical study titled "Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma". The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
What is the current status of trial NCT02136134?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 498 participants. The study started on 2014-08-15. Estimated completion is 2024-01-10.
What interventions are being tested in trial NCT02136134?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (DRUG), VELCADE (Bortezomib) (DRUG).
Who is sponsoring clinical trial NCT02136134?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02136134's enrollment target sits among peer trials
498 775th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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