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Active, not recruiting Phase 3 Interventional

A Study of Daratumumab

ClinicalTrials.gov ID: NCT05438043

Public ClinicalTrials.gov record NCT05438043. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 7:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

Study identification

NCT ID
NCT05438043
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
213 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 14, 2022
Primary completion
Jan 30, 2029
Completion
Jan 30, 2029
Last update posted
Aug 27, 2026

2022 – 2029

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
University of Miami Sylvester Cancer Center Miami Florida 33136
Emory University Atlanta Georgia 30322
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109
Barnes-jewish Hospital St Louis Missouri 63108
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg New York New York 10029
Memorial Sloan Kettering Cancer Center New York New York 10065
Baylor University Medical Center Dallas Texas 75246

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 85 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05438043, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05438043 live on ClinicalTrials.gov.

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