Combining Daratumumab, Venetoclax, and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study
This study is testing a new combination of three medications to see if they can help people with newly diagnosed light-chain amyloidosis who have a specific genetic marker feel better and respond faster than with current treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | daratumumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06629818 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination therapy using daratumumab, venetoclax, and dexamethasone in patients with newly diagnosed light-chain amyloidosis who have a specific genetic marker (translocation t(11;14)). The study aims to prospectively assess how well this treatment works compared to existing therapies, particularly focusing on the rapid and profound hematologic response observed in previous studies. Participants will receive either intravenous or subcutaneous daratumumab along with the other medications. The trial is designed to provide valuable insights into a promising treatment approach for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are treatment-naïve patients diagnosed with light-chain amyloidosis who have a confirmed t(11;14) genetic translocation.
Not a fit: Patients with uncontrolled infections, other active malignancies, or certain cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with light-chain amyloidosis by providing a more effective therapy option.
How similar studies have performed: Previous studies have shown promising results with venetoclax-based therapies in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Kaini Shen
- Email: shenkaini3@sina.com
- Phone: 86-13693339884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.