ClinicalTrials.gov record NCT07224672

A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis

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

A Phase 2, Open-label, Randomized, Dose Optimization Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)

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 and older
SexAll
LocationAustralia, United States
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 Phase 2, open-label study enrolls adults with newly diagnosed AL (amyloid light-chain) amyloidosis. It randomizes participants into a dose-optimization phase and then a dose-expansion phase to receive belantamab mafodotin combined with cyclophosphamide, bortezomib, and dexamethasone (CyBorD). The study will assess hematologic and organ responses and collect safety and drug-level data over months to years of follow-up.

What it is studying. The study tests giving belantamab mafodotin together with the chemotherapy regimen cyclophosphamide, bortezomib, and dexamethasone (CyBorD) in newly diagnosed AL amyloidosis to assess hematologic response, organ responses, safety, and drug levels.

What the researchers hope to learn. Measure overall complete hematologic response rate; record organ response rates (cardiac, renal, liver); track adverse events and ocular findings; and characterize pharmacokinetics and anti-drug antibodies for belantamab mafodotin.

What this study is about

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

The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) 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
  • Belantamab mafodotin
  • Cyclophosphamide
  • Bortezomib
  • Dexamethasone

Eligibility

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

Inclusion criteria

  • Participant is at least 18 years of age or the legal age of consent
  • Has histologically confirmed newly diagnosed primary AL amyloidosis according to the following criteria:
  • Presence of an amyloid-related systemic syndrome as per consensus guidelines.
  • Positive amyloid staining by Congo red stain with green birefringence on polarized light microscopy in any tissue AND at least 1 of the following tests to confirm amyloid type as AL Characteristic appearance by electron microscopy or confirmatory immunohistochemistry or AL amyloidosis typing by mass spectrometric proteomic analysis of the amyloid deposits or amyloid-typing by immunofluorescence oEvidence of a monoclonal plasma cell proliferative disorder
  • Measurable clonal disease as defined by at least 1 of the following:
  • Serum monoclonal protein >=0.5 grams per deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation performed at central laboratory),
  • Involved serum FLC >=5.0 milligram per deciliter (mg/dL) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved light chain, FLC concentrations (dFLC) >=5 mg/dL.
  • Not considered candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) as part of first line of therapy
  • Is willing to use adequate contraception.
  • Is capable of giving signed informed consent
  • Has an Eastern Cooperative Oncology Group performance status of 0, 1 or 2
  • Has adequate hematologic, hepatic and renal function

Exclusion criteria

  • Has a previous or current diagnosis of plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome or symptomatic multiple myeloma (MM), as per International Myeloma Working Group criteria for MM including the presence of lytic bone disease , plasmacytomas, or clonal BM plasma cells >=60%.
  • Has Immunoglobulin M (IgM)-related AL amyloidosis.
  • Has any form of non-AL amyloidosis, including wild type or mutated (Transthyretin amyloidosis [ATTR]) amyloidosis.
  • Has evidence of significant cardiovascular (CV) conditions as specified below:
  • New York Heart Association (NYHA) classification IIIb or IV heart failure.
  • Heart failure that in the opinion of the investigator is caused by ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrected valvular disease and not primarily due to AL amyloidosis cardiomyopathy.
  • In-participant admission to a hospital for unstable angina or myocardial infarction within the last 3 months prior to screening or percutaneous cardiac intervention with recent stent within last 3 months prior to screening or coronary artery bypass grafting within the last 3 months prior to screening
  • Participants with current evidence of clinically significant untreated arrhythmia(s), including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block.
  • Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular nodal or sinoatrial nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillator is indicated but not placed (participants who do have a pacemaker/implantable cardioverter-defibrillator are allowed on the study).
  • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >450 millisecond (msec) or >480 msec for participants with bundle branch block. Participants who have a pacemaker may be included regardless of calculated QTc interval.
  • Supine systolic blood pressure <90 millimeters of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of >20 mmHg despite medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion.
  • Uncontrolled hypertension.
  • Has Mayo stage 3B disease
  • Has a current corneal epithelial disease except for mild punctate keratopathy.
  • Has previous or concurrent malignancies other than AL amyloidosis, except for any other malignancy that has been considered medically stable for at least 2 yearsThe participant must not be receiving active therapy, other than hormonal therapy for this disease.
  • Has major surgery within 2 weeks prior to the first dose of study interventions or has not recovered fully from surgery.
  • Has any history of prior allogenic or autologous BM transplant or other solid organ transplant.
  • Has known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, cyclophosphamide, bortezomib, boron or mannitol
  • Has active infection or active bleeding.
  • Has intolerance or contraindications to antiviral prophylaxis.
  • Has known Human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
  • Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/milliliter (mL) Cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts >=350 cells/microliter.
  • No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.
  • Has prior therapy for AL amyloidosis or MM, with the exception of 160 milligram (mg) dexamethasone (or equivalent corticosteroid) maximum exposure prior to enrollment.
  • Has received any live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin
  • Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of interventional medical research within 28 days before enrollment.
  • Has an alanine aminotransferase (ALT) value >2.5*upper limit of normal (ULN) or >3*ULN if hepatic involvement of AL amyloidosis
  • Has a total bilirubin value >1.5*ULN
  • Has cirrhosis or current unstable liver or biliary disease per investigator assessment Has documented presence of Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of study intervention, unless HBV DNA is undetectable at screening and participant receives antiviral prophylaxis or treatment.
  • Has a positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention unless the following criteria are met:
  • RNA test negative.
  • Successful antiviral treatment (usually 8 weeks duration), followed by a negative Hepatitis C virus RNA test after a washout period of at least 4 weeks.
  • Chronic hepatitis B infection, with the presence of HBsAg and/or detectable hepatitis B virus deoxyribonucleic acid (HBV DNA), and hepatitis D co-infection, with hepatitis D antibody and/or RNA, within 3 months

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 are treated with belantamab mafodotin combined with cyclophosphamide, bortezomib, and dexamethasone in a randomized dose‑optimization phase followed by a dose‑expansion phase at the selected dose. They will have regular safety and efficacy assessments including ophthalmic (eye) examinations, laboratory tests, and blood sampling for drug levels and anti‑drug antibodies. The study team will monitor hematologic responses and adverse events for up to approximately 24 months and follow organ responses and response duration for up to approximately 5 years. The registry record does not list additional participant services.

How the study is structured. Interventional Phase 2 treatment study. Open-label and randomized with a dose-optimization stage followed by a dose-expansion stage. Participants receive assigned drug combinations (belantamab mafodotin plus CyBorD) and are followed for response, side effects, and blood drug measurements. There is no masking (everyone and the study team know which dose is given).

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 Australia, United States. 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

Important dates

Study start
Jun 24, 2026
Primary completion
Jan 12, 2033 (estimated)
Study completion
Jan 12, 2033 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Jul 17, 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
GlaxoSmithKline

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 (5)

Terms used on this page · explanations by MedicalUpdates.ai

histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
FLC
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.
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.
ASCT
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
line of therapy
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
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.
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.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
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.
washout period
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
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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