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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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
Show all 11Show fewer
  • 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

Other trials in China

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.

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 groups in NCT06629818
Study groupRoleWhat they receive
Dara-VenDExperimentalDaratumumab 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.

  1. Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation

    Measured: 3 months after treatment initiation

Secondary outcomes (17)

  1. Overall survival

    Measured: 2 years

  2. Time to next treatment

    Measured: 2 years

  3. CR+VGPR at 1 month after treatment initiation

    Measured: 1 month after treatment initiation

  4. CR+VGPR at 6 months after treatment initiation

    Measured: 6 months after treatment initiation

  5. CR+VGPR at 12 months after treatment initiation

    Measured: 12 months after treatment initiation

  6. Difference between involved and uninvolved free light chain (dFLC) < 10mg/L

    Measured: at 1, 3, 6 and 12 months after treatment initiation

  7. Involved free light chain (iFLC) ≤ 20mg/L

    Measured: at 1, 3, 6 and 12 months after treatment initiation

  8. Minimal residual disease (MRD) negativity

    Measured: 12 months after treatment initiation

  9. Time to hematologic response

    Measured: 1 year

  10. Time to hematologic CR

    Measured: 1 year

  11. Cardiac response

    Measured: at 3, 6 and 12 months after treatment initiation

  12. Renal response

    Measured: at 3, 6 and 12 months after treatment initiation

  13. Hepatic response

    Measured: at 3, 6 and 12 months after treatment initiation

  14. Time to cardiac response

    Measured: 2 years

  15. Time to renal response

    Measured: 2 years

  16. Time to hepatic response

    Measured: 2 years

  17. 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.

  1. First posted8 Oct 2024
  2. Study start15 Oct 2024
  3. Primary completion14 Oct 2026 (estimated)
  4. Study completion14 Mar 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation (time frame: 3 months after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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