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NCT02195479 · ClinicalTrials.gov registry record · Phase 3
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 706
- Enrollment target
NCT02195479: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02195479 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 706 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
NCT02195479, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 706 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).
Primary Outcome
PFS: duration from date of randomization to progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 grams per deciliter \[g/dL\]); Urine M-component (absolute increase \>=200 milligrams \[mg\]/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase \>10
Interventions
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Prednisone
- DRUG Velcade
- DRUG Daratumumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 706 participants |
| Start Date | 2014-12-09 |
| Est. Completion | 2024-08-07 |
| Phase | Phase 3 |
What the finished NCT02195479 record still lists
NCT02195479 is an interventional study that assigns participants to a tested intervention. The registered 706 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 5 interventions - of which Melphalan is the first listed.
NCT02195479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02195479 about?
NCT02195479 is a clinical study titled "A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma". The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy an...
What is the current status of trial NCT02195479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 706 participants. The study started on 2014-12-09. Estimated completion is 2024-08-07.
What interventions are being tested in trial NCT02195479?
The interventions under investigation include: Melphalan (DRUG), Dexamethasone (DRUG), Prednisone (DRUG), Velcade (DRUG), Daratumumab IV (DRUG).
Who is sponsoring clinical trial NCT02195479?
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 NCT02195479's enrollment target sits among peer trials
706 505th of 2000 higher than 1,496 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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