Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03412565 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
NCT03412565: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03412565 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 265 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03412565, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
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. 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) per 24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light
Interventions
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2018-04-26 |
| Est. Completion | 2024-04-18 |
| Phase | Phase 2 |
What the finished NCT03412565 record still lists
NCT03412565 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT03412565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03412565 about?
NCT03412565 is a clinical study titled "A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens". The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
What is the current status of trial NCT03412565?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2018-04-26. Estimated completion is 2024-04-18.
What interventions are being tested in trial NCT03412565?
The interventions under investigation include: Melphalan (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT03412565?
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 NCT03412565's enrollment target sits among peer trials
265 210th of 2000 higher than 1,791 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
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
- NCT05443126 · 265 participants · Phase 1
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
- NCT05470491 · 265 participants · Phase 1
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
- NCT07301905 · 265 participants · NA
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
- NCT07470853 · 265 participants · Phase 1
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
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