Rapid dFLC Response Predict CHR in AL Amyloidosis

March 6, 2026 updated by: Jin Lu, MD, Peking University People's Hospital

Rapid dFLC Response Predict Complete Hematologica Response in Systemic AL Amyloidosis Patients Treated With Daratumumab-based Regimen

Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

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
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100045
        • Recruiting
        • Fuxing Hospital affiliated to Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, China, 101118
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Chinese PLA Eastern Theater General Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Systemic AL amyloidosis patients with evaluable hematologic parameter

Description

Inclusion Criteria:

  1. Diagnosis of systemic AL amyloidosis;
  2. Daratumumab, bortezomib, dexamethasone used in treatment;
  3. Informed consent explained to, understood by and signed by the patient;
  4. dFLC ≥ 50 mg/L;

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+]); Patients with HIV infection or syphilis infection;
  6. 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1

All patients in this cohort receive daratumumab, bortezomib and dexamethasone as treatment.

All patients receive additional sFLC examination in C1D7, C1D14.
Drug: Dara IV
The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.
Drug: Bortezomib (drug)
Bortezomib is administered subcutaneously. The dosage range from 0.7 to 1.3 mg/m2 on days 1, 8, 15, and 22 of each cycle, for a maximum of 6 cycles
Drug: Dexamethasone
Dexamethasone is administered intravenously at a dose of 40 mg weekly for each cycle, for a maximum of 6 cycles. For patients over 70 years of age or with severe edema, heart failure, or uncontrolled diabetes mellitus, dexamethasone can be administered at a dose of 10-20 mg per week.
Drug: Cyclophosphamide (CTX)
Some patients may receive cyclophosphamide orally or intravenously at a dosage of 300 mg/m2 weekly.
Drug: Dara SC
The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete hematologic response
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall hematologic response
Time Frame: 6 months
6 months
At least one organ response
Time Frame: 12 months
12 months
Minimal residual disease
Time Frame: 6 months, 12 months
Bone marrow miminal residual disease
6 months, 12 months
TTNT
Time Frame: 12 months
Time to next treatment
12 months
MOD-EFS
Time Frame: 12 months
Major Organ Deterioration Event-Free Survival (MOD-EFS) is defined as the time from the beginning of treatment to hematologic progression, clinical manifestation of end-stage cardiac or renal disease, initiation of subsequent other anti-plasma cell therapy, or death, whichever occur first
12 months
MOD-PFS
Time Frame: 12 months
Major organ deterioration progression-free survival (MOD-PFS) is defined as the time from the beginning of treatment to death, clinical manifestation of end-stage cardiac or renal failure, or hematologic progression, whichever occur first
12 months

Collaborators and Investigators

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

Sponsor

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)

October 26, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 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

  • 2023PHB319-001-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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