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NCT02519452 · ClinicalTrials.gov registry record · Phase 1
A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT02519452 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 120 participants.
The verdict
NCT02519452, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration via SC delivery of daratumumab (Part 2) and to evaluate the safety of Dara-CF 1800 milligram (mg) SC delivery without pre-dose and post-dose corticosteroids (Part 3).
Interventions
- DRUG Daratumumab Subcutaneous (SC) Administration
- DRUG Recombinant Human Hyaluronidase [rHuPH20]) SC Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-10-22 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02519452
The ClinicalTrials.gov registry entry for NCT02519452 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Daratumumab Subcutaneous (SC) Administration is the first listed.
NCT02519452 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02519452 about?
NCT02519452 is a clinical study titled "A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma". The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration via SC delivery of daratumu...
What is the current status of trial NCT02519452?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2015-10-22. Estimated completion is 2023-04-03.
What interventions are being tested in trial NCT02519452?
The interventions under investigation include: Daratumumab Subcutaneous (SC) Administration (DRUG), Recombinant Human Hyaluronidase [rHuPH20]) SC Administration (DRUG).
Who is sponsoring clinical trial NCT02519452?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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