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RECRUITING
NCT06455748
NA

Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study

Sponsor: Yongyong MA

View on ClinicalTrials.gov

Summary

This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-03-01

Completion Date

2025-03-01

Last Updated

2024-06-12

Healthy Volunteers

No

Interventions

DRUG

Daratumumab/daratumumab and hyaluronidase-fihj

Daratumumab/daratumumab and hyaluronidase-fihj: Dara SC 1800mg subcutaneous (IH) or Dara 16mg/kg intravenously (IV) administered weekly (qwk) x 4 every 2 weeks X 3 doses per month starting C7.

DRUG

Pomalidomide

Pomalidomide: pom 2-4mg PO day (D) 1-21/28 (adjust dose for renal function).

DRUG

Dexamethasone

Dexamethasone: dex C1: 20mg IV D1/8, 20mg PO D2/9 and 40mg PO C1D15 weekly up to C6, then 20mg IV monthly starting C7D1 and 20mg PO D8, 15, 22.

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China