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NCT03201965 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

A Phase 3 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
416
Enrollment target

NCT03201965 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 416 participants.

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The verdict

NCT03201965, a Phase 3 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
416 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Daratumumab
  • DRUG Bortezomib
  • DRUG Dexamethasone, 40 mg

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2017-10-05
Est. Completion 2024-11-19
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT03201965

The ClinicalTrials.gov registry entry for NCT03201965 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 416 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 4 interventions - of which Cyclophosphamide is the first listed.

NCT03201965 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03201965 about?

NCT03201965 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis". The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

What is the current status of trial NCT03201965?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2017-10-05. Estimated completion is 2024-11-19.

What interventions are being tested in trial NCT03201965?

The interventions under investigation include: Cyclophosphamide (DRUG), Daratumumab (DRUG), Bortezomib (DRUG), Dexamethasone, 40 mg (DRUG).

Who is sponsoring clinical trial NCT03201965?

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.