Status:
UNKNOWN
Daratumumab Combined With Bortezomib and Dexamethasone in Mayo 04 Stage III Light Chain Amyloidosis
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Amyloidosis; Systemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with light chain (AL) amyloidosis who have advanced cardiac damage are at risk of premature mortality. There is ongoing unmet need for effective therapies to rapidly induce deep hematologic r...
Eligibility Criteria
Inclusion
- 18 years old adults.
- Biopsy proved treatment-naïve AL amyloidosis.
- Mayo 2004 stage III.
- dFLC \> 50mg/L.
- Patient must provide informed consent.
Exclusion
- Co-morbidity of uncontrolled infection.
- Co-morbidity of other active malignancy.
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia.
- Co-morbidity of grade 2 or 3 atrioventricular block.
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia.
- Seropositive for human immunodeficiency virus.
- Seropositive for hepatitis B (positive test for HBsAg). Participants with resolved infection (ie, HBsAg negative but positive for anti-HBc and/or anti-HBs) must be screened of HBV-DNA. Those who are PCR positive will be excluded.
- Seropositive for hepatitis C (except in the setting of a sustained virologic response).
- Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
- Neutrophil \<1×10E9/L，hemoglobin \< 7g/dL，or platelet \< 75×10E9/L.
- Severely compromised hepatic or renal function: ALT or AST \> 2.5 × ULN, total bilirubin \> 1.5mg/dL，or eGFR \< 40mL/min (those with renal dysfunction due to renal involvement or renal hypoperfusion from cardiac amyloidosis could be included)
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04474938
Start Date
May 24 2021
End Date
March 1 2024
Last Update
May 10 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730