Light Chain (AL) AmyloidosisPhase 2NCT06629818
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
A Phase 2 study testing Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous), Venetoclax and Dexamethasone in people with Light Chain (AL) Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Light Chain (AL) Amyloidosis
- What is being tested?
- Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous), Venetoclax and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 14 Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proved treatment-naïve AL amyloidosis
- Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
- dFLC > 50mg/L
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study
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.
- Conditions
- Light Chain (AL) Amyloidosis
- Being tested
- Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous), Venetoclax, Dexamethasone
- Keywords
- Light Chain (AL) Amyloidosis, CCND1 Translocation, Venetoclax, Daratumumab
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)Drug
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
VenetoclaxDrug
400mg po qd for 1 year
DexamethasoneDrug
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
| Study group | Role | What they receive |
|---|---|---|
| Dara-VenD | Experimental | Daratumumab combined with venetoclax and dexamethasone Receives: Drug: Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous); Drug: Venetoclax; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation
Measured: 3 months after treatment initiation
Secondary outcomes (17)
Overall survival
Measured: 2 years
Time to next treatment
Measured: 2 years
CR+VGPR at 1 month after treatment initiation
Measured: 1 month after treatment initiation
CR+VGPR at 6 months after treatment initiation
Measured: 6 months after treatment initiation
CR+VGPR at 12 months after treatment initiation
Measured: 12 months after treatment initiation
Difference between involved and uninvolved free light chain (dFLC) < 10mg/L
Measured: at 1, 3, 6 and 12 months after treatment initiation
Involved free light chain (iFLC) ≤ 20mg/L
Measured: at 1, 3, 6 and 12 months after treatment initiation
Minimal residual disease (MRD) negativity
Measured: 12 months after treatment initiation
Time to hematologic response
Measured: 1 year
Time to hematologic CR
Measured: 1 year
Cardiac response
Measured: at 3, 6 and 12 months after treatment initiation
Renal response
Measured: at 3, 6 and 12 months after treatment initiation
Hepatic response
Measured: at 3, 6 and 12 months after treatment initiation
Time to cardiac response
Measured: 2 years
Time to renal response
Measured: 2 years
Time to hepatic response
Measured: 2 years
Adverse events
Measured: treatment initiation to 30 days after last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Oct 2024
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Chain (AL) AmyloidosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629818
- Sponsor's protocol ID
- Dara-VenD001
- Status last verified
- Jul 2026
- First submitted
- 3 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No