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NCT02316106 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT02316106: Completed Phase 2 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT02316106 is a Phase 2 study of Multiple Myeloma that has completed, run by Janssen Research & Development. The registered enrollment target is 123 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316106, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
Primary Outcome
Percentage of participants who achieved a CR by IMWG Criteria were reported. CR was defined as CR plus stringent complete Response (sCR) by IMWG criteria. Per IMWG criteria, CR response was defined as a negative immunofixation on the serum and urine, and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Conditions Studied
Interventions
- DRUG daratumumab
Study Locations (20)
Other
- - Box Hill
- - Concord
- - Melbourne
- - Woodville South
Florida
- - Jacksonville
- - West Palm Beach
Ohio
- - Cincinnati
- - Columbus
Arkansas
- - Little Rock
Georgia
- - Atlanta
Massachusetts
- - Boston
Michigan
- - Ann Arbor
Missouri
- - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2015-05-20 |
| Est. Completion | 2024-06-03 |
| Phase | Phase 2 |
What the finished NCT02316106 record still lists
NCT02316106 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which daratumumab is the first listed.
NCT02316106 names 20 study sites across 15 states, led by Other, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT02316106 about?
NCT02316106 is a clinical study titled "A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma". The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
What is the current status of trial NCT02316106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2015-05-20. Estimated completion is 2024-06-03.
What conditions does trial NCT02316106 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT02316106?
The interventions under investigation include: daratumumab (DRUG).
Who is sponsoring clinical trial NCT02316106?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02316106 being conducted?
This trial has 20 study locations across Arkansas, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02316106's enrollment target sits among peer trials
123 149th of 438 higher than 289 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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