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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05277493
Other study ID # AL amyloidosis registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2022
Est. completion date September 2025

Study information

Verified date April 2022
Source Peking Union Medical College Hospital
Contact Daobin Zhou, MD
Phone 69155020
Email zhoudb@pumch.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 2025
Est. primary completion date March 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematologic complete response at 3 months 3 months
See also
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Completed NCT03236792 - Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis Phase 1/Phase 2
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