A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab

Recruiting

• Conditions: AL Amyloidosis

• Registration Number: NCT05277493
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The purpose of this protocol is to generate a registry of Chinese patients with AL amyloidosis treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-03-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 18 years and older
• newly diagnosed or refractory/relapsed AL amyloidosis
• treated with subcutaneous/intravenous daratumumab alone or subcutaneous/intravenous daratumumab combined with chemotherapy

Exclusion Criteria

• co-diagnosis of multiple myeloma or Waldenström's macroglobulinemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematologic complete response at 3 months	3 months

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China