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ACTIVE NOT RECRUITING Phase 3

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

NCT03301220 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 390 participants
Start Date 2017-11-07
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03301220

The ClinicalTrials.gov registry entry for NCT03301220 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03301220 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03301220?

The interventions under investigation include: Daratumumab SC: daratumumab + rHuPH20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03301220?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial