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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 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.

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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).

Conditions Studied

Smoldering Multiple Myeloma

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

593 total trials

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What the Registry Record Tells You About NCT03301220

The ClinicalTrials.gov registry entry for NCT03301220 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 780-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (50% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.