Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03301220 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
A Phase 3 study of Smoldering Multiple Myeloma, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
- 20
- Study locations
NCT03301220: Active Phase 3 study of Smoldering Multiple Myeloma, sponsored by Janssen Research & Development.
NCT03301220 is a Phase 3 study of Smoldering Multiple Myeloma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 390 participants, below the 780-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301220, a Phase 3 study of Smoldering Multiple Myeloma, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
Primary Outcome
PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonan
Conditions Studied
Interventions
- DRUG Daratumumab SC: daratumumab + rHuPH20
Study Locations (20)
New York
- New York Oncology Hematology - Albany
- Stony Brook University Medical Center - Stony Brook
North Carolina
- University of North Carolina - Chapel Hill
- Levine Cancer Institute, Carolinas HealthCare System - Charlotte
Ohio
- Cleveland Clinic - Cleveland
- The Ohio State University - Columbus
Arizona
- Arizona Oncology Associates, PC - HAL - Phoenix
California
- Innovative Clinical Research Inc - Whittier
Florida
- Miami Cancer Institute - Miami
Georgia
- Emory University - Atlanta
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03301220 still lists
NCT03301220 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 780-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Smoldering Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab SC: daratumumab + rHuPH20 is the first listed.
NCT03301220 names 20 study sites across 17 states, led by New York, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT03301220 about?
NCT03301220 is a clinical study titled "A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma". The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
What is the current status of trial NCT03301220?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2017-11-07. Estimated completion is 2026-06-30.
What conditions does trial NCT03301220 study?
This clinical trial studies the following conditions: Smoldering Multiple Myeloma.
What interventions are being tested in trial NCT03301220?
The interventions under investigation include: Daratumumab SC: daratumumab + rHuPH20 (DRUG).
Who is sponsoring clinical trial NCT03301220?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03301220 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoldering Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03301220's enrollment target sits among peer trials
390 7th of 20 higher than 14 of 20 other Smoldering Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoldering Multiple Myeloma 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
-
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
ACTIVE NOT RECRUITING · Phase 3
-
Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
ACTIVE NOT RECRUITING · Phase 3
-
Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
RECRUITING · Phase 2
-
Smoldering Myeloma High-Risk Patient Observation and Longitudinal Insight Trial
RECRUITING
-
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
RECRUITING
-
Registry for Adults With Plasma Cell Disorders (PCD's)
RECRUITING
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
- NCT00397111 · 390 participants
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
- NCT05335928 · 390 participants · Phase 3
Abatacept in Immune Checkpoint Inhibitor Myocarditis
- NCT05445960 · 390 participants · NA
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
- NCT05997615 · 390 participants · Phase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
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