NCT06455748

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yongyong MA · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary objective: Hematologic overall remission rate (ORR) as defined by the criteria in the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light Chain Amyloidosis, 2021 edition. Secondary objective: 1. organ remission rate as defined by the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Systemic Light-Chain Amyloidosis 2021 Edition, hematologic complete remission (CR) rate, very good partial remission (VGPR) rate, progression free survival (PFS), overall survival (OS), and negative rate of microscopic residual disease (MRD). 2. safety of combination therapy regimens. Exploratory purpose: EORTC QLQ-C30.

Conditions

• Amyloid Light-chain Amyloidosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: China