An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

ClinicalTrials.gov ID: NCT01985126

Public ClinicalTrials.gov record NCT01985126. 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.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 10:55 AM EDT

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Official title

An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a Proteasome Inhibitor and an IMiD

Brief summary

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

The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD.

Study identification

NCT ID: NCT01985126
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 124 participants

Conditions and interventions

Conditions

Multiple Myeloma

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
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: Sep 27, 2013 (Actual)
Primary completion: Jan 9, 2015 (Actual)
Completion: May 30, 2017 (Actual)
Last update posted: Jun 25, 2018

2013 – 2017

United States locations

U.S. sites: 15
U.S. states: 13
U.S. cities: 15

Facility	City	State	ZIP	Site status
Not listed	Duarte	California	—	—
Not listed	Los Angeles	California	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Chicago	Illinois	—	—
Not listed	Louisville	Kentucky	—	—
Not listed	Detroit	Michigan	—	—
Not listed	New Brunswick	New Jersey	—	—
Not listed	New York	New York	—	—
Not listed	Chapel Hill	North Carolina	—	—
Not listed	Charlotte	North Carolina	—	—
Not listed	Portland	Oregon	—	—
Not listed	Philadelphia	Pennsylvania	—	—
Not listed	Nashville	Tennessee	—	—
Not listed	Houston	Texas	—	—
Not listed	Madison	Wisconsin	—	—

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 8 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01985126, 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 Jun 25, 2018 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01985126 live on ClinicalTrials.gov.

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