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A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

NCT05250973 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

Conditions

  • Amyloidosis

Interventions

DRUG

Daratumumab

Daratumumab will be administered subcutaneously.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered either orally or IV.

DRUG

Bortezomib

Bortezomib will be administered by SC injection or IV.

DRUG

Dexamethasone

Dexamethasone will be administered orally or IV.

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
2022-03-01
Primary Completion
2025-05-30
Completion
2026-10-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT05250973 on ClinicalTrials.gov