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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

NCT03201965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2025-11-26

Study results available
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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.

Conditions

  • Amyloidosis

Interventions

DRUG

Cyclophosphamide

Participants will receive 300 mg/m\^2 of cyclophosphamide as an oral or IV dose.

DRUG

Bortezomib

Participants will receive 1.3 mg/m\^2 of bortezomib as an subcutaneous (SC) injection.

DRUG

Dexamethasone, 40 mg

Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.

DRUG

Daratumumab

Participants will receive 1800 mg of daratumumab subcutaneously.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2020-02-14
Completion
2024-11-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201965 on ClinicalTrials.gov