Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study
Peking Union Medical College Hospital
36 participants
Oct 15, 2024
INTERVENTIONAL
Conditions
Summary
Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.
Eligibility
Inclusion Criteria3
- Biopsy proved treatment-naïve AL amyloidosis
- Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
- dFLC \> 50mg/L
Exclusion Criteria11
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- Seropositive for human immunodeficiency virus
- Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug
- Neutrophil \<1×10E9/L，hemoglobin \< 8g/dL，or platelet \< 100×10E9/L
- Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN), total bilirubin \> 3 × ULN，eGFR \< 15 mL/min, or receiving renal replacement therapy
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Interventions
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
400mg po qd for 1 year
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06629818