ClinicalTrials.gov record NCT06376214

Daratumumab for Patients With Light Chain Amyloidosis

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

Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Apr 19, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old to 75 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 randomized study assigns people with newly diagnosed systemic light chain (AL) amyloidosis to one of three daratumumab-based strategies: long-term daratumumab plus dexamethasone, daratumumab plus autologous stem cell transplant (ASCT) after two treatment courses, or daratumumab with dexamethasone and pomalidomide (DPD) for stage IIIB disease. Daratumumab is given by infusion on a weekly → every-2-weeks → monthly schedule; DPD includes up to six cycles of pomalidomide. Treatment may continue until progression, unacceptable toxicity, or withdrawal. Disease assessments are planned every three months.

What it is studying. The study is testing the safety and effectiveness of different daratumumab-based treatment strategies (long-term daratumumab, daratumumab followed by ASCT, and daratumumab+dexamethasone+pomalidomide) in people with newly diagnosed systemic light chain (AL) amyloidosis.

What the researchers hope to learn. To observe hematologic complete response rate at 6 months and organ response rate at 1 year. Secondary goals include measuring time to next treatment, progression-free survival over 3 years, and overall survival over 5 years. To collect safety information on the tested regimens.

What this study is about

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

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.

Interventions being studied

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

Drug
  • Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
  • Pomalidomide 4 MG
Procedure
  • autologous stem cell transplantation (ASCT)

Eligibility

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

Inclusion criteria

  • Participants must be aged ≥18 and ≤75 years;
  • Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
  • In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP>8500ng/L and cTnT>0.035μg/L or cTnI>0.01g/L;
  • Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
  • Expected survival ≥ 12 weeks;
  • ECOG performance status≤ 2;
  • Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of <1% per year.

Exclusion criteria

  • eGFR< 30ml/min/1.73m2;
  • Combined multiple myeloma;
  • Acute or chronic infection requiring treatment within 30 days prior to baseline;
  • Pregnant or breastfeeding women.
  • Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
  • Other conditions deemed by the researcher as unsuitable for enrollment.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen (group A) and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen (group B) , and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment (group C). Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression. Group C were given Daratumumab (16mg/kg), dexamethasone (40mg) and pomalidomide. The usage of Daratumumab and dexamethasone is the same as group A and B. Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. The dose of pomalidomide is adjusted based on the patient's renal function and ECOG score.

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 infusions (once weekly for 2 months, then every 2 weeks for 4 months, then monthly); in arm A the monthly phase is described as lasting 18 months. Some participants (arm B) receive two daratumumab+dexamethasone courses followed by autologous stem cell transplantation, which includes stem-cell mobilization and high-dose melphalan conditioning. Stage IIIB participants (arm C) receive daratumumab and dexamethasone plus oral pomalidomide on days 1–21 of a 28-day cycle for cycles 1–6, with pomalidomide dose adjusted for renal function and ECOG status. Disease evaluations are performed every three months until progression; treatment may continue until disease progression, unacceptable toxicity, or withdrawal.

How the study is structured. Interventional, randomized, open-label study with three parallel treatment groups. Participants receive assigned daratumumab-based therapy (one group may later receive ASCT; one group receives pomalidomide for up to six cycles). Treatments are not blinded. Participants are followed with regular disease evaluations every three months.

Questions you could ask

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

  • 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
Jan 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Apr 19, 2024
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
Nanjing University School of Medicine
Principal investigator
Zhi-Hong Liu, MD, Professor
Nanjing University School of Medicine

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 (1)

  • National Clinical Research Center for Kidney Diseases, Jinling HospitalRecruiting

    Nanjing, Jiangsu, 210016 · China

Terms used on this page · explanations by MedicalUpdates.ai

standard treatment
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
informed consent form
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.
ECOG performance status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
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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