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NCT00574288 · ClinicalTrials.gov registry record · Phase 2
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT00574288: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT00574288 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00574288, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Interventions
- DRUG Part 1: Daratumumab
- DRUG Part 2: Daratumumab
- OTHER Methylprednisolone
- OTHER Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2008-03-26 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 2 |
What the finished NCT00574288 record still lists
NCT00574288 is an interventional study that assigns participants to a tested intervention. The registered 104 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 (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Part 1: Daratumumab is the first listed.
NCT00574288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00574288 about?
NCT00574288 is a clinical study titled "Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma". Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.
What is the current status of trial NCT00574288?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2008-03-26. Estimated completion is 2017-04-03.
What interventions are being tested in trial NCT00574288?
The interventions under investigation include: Part 1: Daratumumab (DRUG), Part 2: Daratumumab (DRUG), Methylprednisolone (OTHER), Dexamethasone (OTHER).
Who is sponsoring clinical trial NCT00574288?
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 NCT00574288's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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