ClinicalTrials.gov record NCT06192979

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

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

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
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.
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 interventional study tests a first-line treatment strategy for systemic AL amyloidosis with t(11;14). All participants start daratumumab, bortezomib, and dexamethasone (DBD). Hematologic response is checked at day 7; rapid responders continue DBD for at least six cycles, while others receive daratumumab, venetoclax, and dexamethasone. The main outcome is complete hematologic response at 6 months.

What it is studying. The study is testing a treatment plan that begins all participants on daratumumab + bortezomib + dexamethasone and uses the hematologic response at day 7 to decide whether to continue that regimen or switch to daratumumab + venetoclax + dexamethasone. The primary measure is the overall complete hematologic response (CHR) rate at 6 months.

What the researchers hope to learn. Primary scientific goal: measure overall complete hematologic response (CHR) rate at 6 months. Secondary goals: measure cardiac, renal, and hepatic responses at 6 months; estimate 2-year progression-free survival and overall survival; assess minimal residual disease (MRD) status at 6 months and treatment-related adverse events up to 6 months.

What this study is about

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

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.

Interventions being studied

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

Drug
  • Daratumumab
  • Bortezomib
  • Dexamethasone
  • Venetoclax

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 1st line treatment;
  • Life expectancy greater than 12 weeks;
  • HGB ≥70g/L;
  • Blood oxygen saturation >90%;
  • Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
  • Informed consent explained to, understood by and signed by the patient.

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

Detailed description from the registry

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.

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.

All participants start treatment with daratumumab + bortezomib + dexamethasone. A hematologic response is assessed at day 7; based on that result you will either continue on the daratumumab + bortezomib + dexamethasone regimen for at least six cycles or receive daratumumab + venetoclax + dexamethasone. Treatment involves drug infusions/injections (daratumumab IV or subcutaneous; bortezomib subcutaneous where used), daily oral venetoclax where assigned, and oral or IV dexamethasone, plus regular clinic visits and tests to monitor blood response, organ (cardiac/renal/hepatic) response and safety up to at least 6 months.

How the study is structured. Interventional, non-randomized, open-label study. Everyone starts the same initial regimen; participants are assigned to one of two treatment paths based on their blood response at day 7. Outcomes and safety are followed over months, with the primary endpoint assessed at 6 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 5, 2024
Primary completion
Sep 30, 2026 (estimated)
Study completion
Mar 31, 2027 (estimated)
Target enrollment
41 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
Jin Lu, MD

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 (6)

Terms used on this page · explanations by MedicalUpdates.ai

Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
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.
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.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

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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