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Active, not recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05250973

Public ClinicalTrials.gov record NCT05250973. 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.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 9:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Brief summary

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

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).

Study identification

NCT ID
NCT05250973
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
151 participants

Conditions and interventions

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
Mar 1, 2022 (Actual)
Primary completion
Feb 4, 2026 (Actual)
Completion
Nov 23, 2026 (Estimated)
Last update posted
Sep 25, 2026

2022 – 2026

United States locations

U.S. sites
16
U.S. states
13
U.S. cities
15
Facility City State ZIP Site status
City of Hope Duarte California 91010 —
Yale New Haven Connecticut 06520 —
Moffitt Cancer Center Tampa Florida 33612 —
Winship Cancer Institute Emory University Atlanta Georgia 30322 —
Tufts Medical Center Boston Massachusetts 02111 —
Boston University Medical Center Boston Massachusetts 02118 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201 —
Memorial Sloan Kettering New York New York 10065 —
Levine Cancer Institute Charlotte North Carolina 28204 —
Wake Forest University - Baptist Medical Center Winston-Salem North Carolina 27157 —
University Hospital of Cleveland Cleveland Ohio 44106 —
Ohio Health Research Institute Columbus Ohio 43214 —
West Penn Hospital Pittsburgh Pennsylvania 15224 —
UT Southwestern Medical Center Dallas Texas 75390 —
VCU Medical Center Richmond Virginia 23298 —
University of Washington Seattle Washington 02118-30002 —

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 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05250973, 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 Sep 25, 2026 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05250973 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →