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Daratumumab for Patients With Light Chain Amyloidosis

NCT06376214 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-19

No results posted yet for this study

Summary

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.

Conditions

  • Light Chain (AL) Amyloidosis

Interventions

DRUG

Dratumumab / Hyaluronidase Injection [Darzalex Faspro]

Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.

DRUG

Pomalidomide 4 MG

Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.

PROCEDURE

autologous stem cell transplantation (ASCT)

The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .

Sponsors & Collaborators

  • Nanjing University School of Medicine

    lead OTHER

Principal Investigators

  • Xianghua Huang, MD · Jinling Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT06376214 on ClinicalTrials.gov