ClinicalTrials.gov record NCT06342466

Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

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

A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis

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.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old to 90 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 open-label Phase 2 study tests a combination of bortezomib, pomalidomide, and dexamethasone (BPd) in people with newly diagnosed or previously treated systemic AL amyloidosis. About 40 participants receive BPd in a single treatment group for up to six 28‑day cycles. The main outcome is the hematologic very good partial response (VGPR) plus complete response (CR) rate at 6 months.

What it is studying. The study measures the hematologic VGPR+CR rate at 6 months after treatment with BPd. Secondary measurements include overall hematologic response, organ responses (cardiac, renal, liver) at 6 months, time to next treatment, progression‑free survival and overall survival at 2 years, and treatment‑related adverse events up to 6 months.

What the researchers hope to learn. To estimate the hematologic VGPR plus CR rate at 6 months after the BPd regimen; to describe overall hematologic response rates and organ responses at 6 months; to measure time to next treatment, progression‑free survival, and overall survival at 2 years; and to record 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.

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.

Interventions being studied

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

Drug
  • Bortezomib
  • Pomalidomide
  • Dexamethasone

Eligibility

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

Inclusion criteria

  • Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.
  • Newly diagnosed or previous treated AL amyloidosis
  • Patients must be ≥ 18 years of age.
  • ECOG performance status 0, 1 or 2.
  • Measurable disease defined by at least one of the following:
  • ① serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).
  • ②. presence of a monoclonal spike that is ≥5 g/l.
  • Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
  • Absolute neutrophil count (ANC) ≥1.0 X 10\^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10\^9/L
  • eGFR ≥20 mL/min/ 1.73 m\^2
  • Written informed consent in accordance with local and institutional guidelines.
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

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

Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.

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 the BPd drug combination in 28‑day cycles for up to six cycles—bortezomib given weekly by subcutaneous injection, pomalidomide taken orally days 1–21, and weekly dexamethasone. They will have clinic visits for drug administration and regular blood tests to measure hematologic response and monitor safety. Treatment stops earlier for disease progression, unacceptable toxicity, or if another therapy is started. Responses are assessed at 6 months, and some outcomes (time to next treatment, progression‑free and overall survival) are followed for up to 2 years.

How the study is structured. Interventional, open‑label, single‑group Phase 2 trial. Participants receive bortezomib (1.3 mg/m2 subcutaneously weekly), pomalidomide (4 mg orally on days 1–21 of each 28‑day cycle), and dexamethasone (20–40 mg weekly) for up to six cycles. There is no masking and all enrolled participants are treated with the same regimen; about 40 subjects are planned.

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
May 6, 2024
Primary completion
December 2026 (estimated)
Study completion
December 2026 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Dec 30, 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
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 (1)

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
very good partial response
A response category used in some blood conditions meaning the disease marker has fallen a great deal but not disappeared. The exact definition depends on the condition and the study.
complete response
No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
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.
serum free light chain
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
difference between involved and uninvolved free light chains
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.
Absolute neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Written 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.

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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