Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
NCT ID: NCT06629818
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-10-15
2026-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dara-VenD
Daratumumab combined with venetoclax and dexamethasone
Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
Venetoclax
400mg po qd for 1 year
Dexamethasone
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
Interventions
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Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
Venetoclax
400mg po qd for 1 year
Dexamethasone
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
Eligibility Criteria
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Inclusion Criteria
* Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
* dFLC \> 50mg/L
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Jian Li
Professor
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Dara-VenD001
Identifier Type: -
Identifier Source: org_study_id
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