Daratumumab Combined with Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)
Phase 2
Recruiting
- Conditions
- Light Chain (AL) Amyloidosis
- Interventions
- Registration Number
- NCT06629818
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Biopsy proved treatment-naïve AL amyloidosis
- Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
- dFLC > 50mg/L
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dara-VenD Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous) Daratumumab combined with venetoclax and dexamethasone Dara-VenD Venetoclax Daratumumab combined with venetoclax and dexamethasone Dara-VenD Dexamethasone Daratumumab combined with venetoclax and dexamethasone
- Primary Outcome Measures
Name Time Method Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation 3 months after treatment initiation
- Secondary Outcome Measures
Name Time Method Overall survival 2 years Time to next treatment 2 years CR+VGPR at 1 month after treatment initiation 1 month after treatment initiation CR+VGPR at 6 months after treatment initiation 6 months after treatment initiation CR+VGPR at 12 months after treatment initiation 12 months after treatment initiation Difference between involved and uninvolved free light chain (dFLC) < 10mg/L at 1, 3, 6 and 12 months after treatment initiation Involved free light chain (iFLC) ≤ 20mg/L at 1, 3, 6 and 12 months after treatment initiation Minimal residual disease (MRD) negativity 12 months after treatment initiation Time to hematologic response 1 year Time to hematologic CR 1 year Cardiac response at 3, 6 and 12 months after treatment initiation Renal response at 3, 6 and 12 months after treatment initiation Hepatic response at 3, 6 and 12 months after treatment initiation Time to cardiac response 2 years Time to renal response 2 years Time to hepatic response 2 years Adverse events treatment initiation to 30 days after last dose of treatment
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, --- Select One ---, China