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NCT03277105 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
NCT03277105 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 522 participants.
The verdict
NCT03277105, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
Study Summary
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
Interventions
- DRUG Dara SC
- DRUG Dara IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2024-01-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03277105
The ClinicalTrials.gov registry entry for NCT03277105 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 522 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 Dara SC is the first listed.
NCT03277105 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03277105 about?
NCT03277105 is a clinical study titled "A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma". The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough conce...
What is the current status of trial NCT03277105?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2017-10-27. Estimated completion is 2024-01-12.
What interventions are being tested in trial NCT03277105?
The interventions under investigation include: Dara SC (DRUG), Dara IV (DRUG).
Who is sponsoring clinical trial NCT03277105?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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