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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277493
Collaborator
(none)
500
Enrollment
1
Location
41.1
Anticipated Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
    Actual Study Start Date :
    Mar 30, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Hematologic complete response at 3 months [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05277493
    Other Study ID Numbers:
    • AL amyloidosis registry
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Immunoglobulin Light-chain Amyloidosis
    Amyloidosis

    Study Results

    No Results Posted as of Apr 27, 2022