Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02519452 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Ctrough: the concentration prior to study drug administration.
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 |
What the finished NCT02519452 record still lists
NCT02519452 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 2 interventions - of which Daratumumab Subcutaneous (SC) Administration is the first listed.
NCT02519452 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02519452's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01174108 · 120 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
- NCT01627301 · 120 participants · NA
Sympathetic Overactivity in Post-traumatic Stress Disorder
- NCT02025023 · 120 participants · Phase 3
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
- NCT02128906 · 120 participants · Phase 2
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI