ClinicalTrials.gov record NCT06627309

Rapid dFLC Response Predict CHR in AL Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 99 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study of people with systemic AL amyloidosis treated with daratumumab-containing regimens. Investigators will measure early changes in dFLC (including checks around day 7 and day 14 of the first cycle) and follow hematologic and organ responses for up to 12 months. The main question is whether an early fall in dFLC predicts a complete hematologic response at 6 months.

What it is studying. The study tests whether an early decrease in dFLC (a blood marker tracked during treatment) predicts later complete hematologic response in patients receiving daratumumab-based therapy. It also collects data on overall hematologic response, organ responses, minimal residual disease in bone marrow, time to next treatment, and major-organ deterioration outcomes.

What the researchers hope to learn. To validate retrospective findings that an early dFLC drop (for example at day 7) may predict complete hematologic response. To describe hematologic and organ responses, minimal residual disease, time to next treatment, and major-organ deterioration outcomes over 6–12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Dara IV
  • Bortezomib (drug)
  • Dexamethasone
  • Cyclophosphamide (CTX)
  • Dara SC

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive daratumumab‑based therapy with bortezomib and dexamethasone (some may also get cyclophosphamide) as part of routine care. Extra blood tests for serum free light chains will be done in cycle 1 on day 7 and day 14. Bone marrow testing for minimal residual disease may be performed at about 6 and 12 months, and clinical assessments of hematologic and organ response are done during roughly one year of follow-up. Other routine tests and clinic visits required for monitoring may also be part of participation.

How the study is structured. A prospective observational cohort: people receive daratumumab-containing treatment per routine care. Study staff add early blood tests (dFLC) during the first cycle and then follow clinical and laboratory outcomes over about one year. No experimental treatment is assigned by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 26, 2024
Primary completion
Jun 30, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Mar 9, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking University People's Hospital
Principal investigator
Jin Lu, MD, Principal of Investigator
Peking University People's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (8)

Terms used on this page · explanations by MedicalUpdates.ai

overall survival
The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
Informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
dFLC
The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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