Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

March 6, 2026 updated by: Jin Lu, MD

Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)

Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
        • Principal Investigator:
          • Jin Lu
      • Beijing, Beijing Municipality, China, 101118
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100045
        • Recruiting
        • Capital Medical University Affiliated Fuxing Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Chinese PLA Eastern Theater General Hospital
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of systemic AL amyloidosis;
  2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;
  3. Life expectancy greater than 12 weeks;
  4. HGB ≥70g/L;
  5. Blood oxygen saturation >90%;
  6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
  7. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

  1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
  2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
  3. Severe or persistent infection that cannot be effectively controlled;
  4. Presence of severe autoimmune diseases or immunodeficiency disease;
  5. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
  6. Patients with HIV infection or syphilis infection;
  7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Rapid Response Group
Daratumumab, bortezomib, dexamethasone
Drug: Daratumumab

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.

Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

Drug: Bortezomib
All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.
Drug: Dexamethasone
All patients received 20-40 mg oral or intravenous dexamethasone
Other: Non-Rapid Response Group
Daratumumab, venetoclax, dexamethasone
Drug: Daratumumab

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles.

Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

Drug: Dexamethasone
All patients received 20-40 mg oral or intravenous dexamethasone
Drug: Venetoclax
All patients received venetoclax 400mg daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall CHR rate at 6 months
Time Frame: Overall CHR rate at 6 months
Overall complete hematologic response rate at 6 months
Overall CHR rate at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac response at 6 months
Time Frame: Cardiac response at 6 months
Cardiac response at 6 months
Cardiac response at 6 months
Renal response at 6 months
Time Frame: Renal response at 6 months
Renal response at 6 months
Renal response at 6 months
Hepatic response at 6 months
Time Frame: Hepatic response at 6 months
Hepatic response at 6 months
Hepatic response at 6 months
Estimated 2-year PFS
Time Frame: Estimated 2-year PFS
Estimated 2-year progression free survival
Estimated 2-year PFS
Estimated 2-year OS
Time Frame: Estimated 2-year overall survival
Estimated 2-year overall survival
Estimated 2-year overall survival
MRD status at 6 months
Time Frame: MRD status at 6 months
Minimal residual disease status at 6 months
MRD status at 6 months
TRAEs
Time Frame: TRAEs
treatment-related adverse events up to 6 months
TRAEs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jin Lu, MD

Investigators

  • Principal Investigator: Jin Lu, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PHB319-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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