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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: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT03277105 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 522 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ORR was defined as the percentage of participants who achieved partial response (PR) or better according to International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 milligrams (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of \>=50% in the difference between invo
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 |
What the finished NCT03277105 record still lists
NCT03277105 is an interventional study that assigns participants to a tested intervention. The registered 522 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Dara SC is the first listed.
NCT03277105 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03277105's enrollment target sits among peer trials
522 716th of 2000 higher than 1,284 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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