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NCT02252172 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 737
- Enrollment target
NCT02252172: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02252172 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 737 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02252172, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 737 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
Primary Outcome
PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to \[\>=\] 0.5 gram per deciliter \[g/dL\] and \>=200 milligram \[mg\]/24 hours respectively); Only in participants without measurable serum and
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab SC
- DRUG Daratumumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 737 participants |
| Start Date | 2015-02-16 |
| Est. Completion | 2024-10-02 |
| Phase | Phase 3 |
What the finished NCT02252172 record still lists
NCT02252172 is an interventional study that assigns participants to a tested intervention. The registered 737 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT02252172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02252172 about?
NCT02252172 is a clinical study titled "Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma". The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are ...
What is the current status of trial NCT02252172?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 737 participants. The study started on 2015-02-16. Estimated completion is 2024-10-02.
What interventions are being tested in trial NCT02252172?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab SC (DRUG), Daratumumab IV (DRUG).
Who is sponsoring clinical trial NCT02252172?
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 NCT02252172's enrollment target sits among peer trials
737 479th of 2000 higher than 1,522 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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