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NCT01985126 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 2
Development phase
124
Enrollment target

NCT01985126 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 124 participants.

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The verdict

NCT01985126, a Phase 2 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
124 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Acetaminophen
  • DRUG Methylprednisolone
  • DRUG Diphenhydramine
  • DRUG Daratumumab 16 mg/kg (Part 1)
  • DRUG Daratumumab 8 mg/kg (Part 1)

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2013-09-27
Est. Completion 2017-05-30
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT01985126

The ClinicalTrials.gov registry entry for NCT01985126 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.

NCT01985126 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01985126 about?

NCT01985126 is a clinical study titled "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". 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...

What is the current status of trial NCT01985126?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2013-09-27. Estimated completion is 2017-05-30.

What interventions are being tested in trial NCT01985126?

The interventions under investigation include: Acetaminophen (DRUG), Methylprednisolone (DRUG), Diphenhydramine (DRUG), Daratumumab 16 mg/kg (Part 1) (DRUG), Daratumumab 8 mg/kg (Part 1) (DRUG).

Who is sponsoring clinical trial NCT01985126?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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

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.