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 Amyloidosis

Overview

About this study

The purpose of this study is to evaluate the efficacy (overall CHR rate) of belantamab mafodotin when administered in combination with CyBorD in participants with ND AL amyloidosis. Secondary objectives include the evaluation of other efficacy parameters, safety, PK, immunogenicity, and clinically observable composite endpoints for MOD-PFS of belantamab mafodotin when administered in combination with CyBorD in participants with ND AL amyloidosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years of age

  • Has histologically confirmed newly diagnosed primary AL amyloidosis

    • Presence of an amyloid-related systemic syndrome with 1 or more organs involved (e.g., renal, liver, heart, gastrointestinal tract, or peripheral nerve involvement, as per consensus guidelines

    • Positive amyloid staining by Congo red stain with apple green birefringence on polarized light microscopy in any tissue (e.g., fat aspirate, BM, or organ biopsy), AND Characteristic appearance by electron microscopy and confirmatory immunohistochemistry or AL amyloidosis-typing by mass spectrometric proteomic analysis of the amyloid deposits or amyloid-typing by immunofluorescence

    • Evidence of a monoclonal plasma cell proliferative disorder (serum or urine monoclonal protein, abnormal free light chain ratio, or clonal plasma cells in the BM)

  • Measurable clonal disease as defined by at least 1 of the following

    • Serum monoclonal protein ≥0.5 g/dL by protein electrophoresis (routine serum protein electrophoresis and immunofixation performed at central laboratory)

    • Serum FLC ≥5.0 mg/dL with an abnormal kappa:lambda ratio or the difference between involved and dFLC ≥5 mg/dL. NOTE: Measurable disease by urine Bence-Jones proteinuria is not sufficient for study enrollment.

  • Not considered candidate for high-dose chemotherapy with ASCT as part of first line of therapy

  • Male and Female participants are willing to use adequate contraception

  • Male participants:

    • During the Treatment period and for at least 6 months after the last dose of study intervention of belantamab mafodotin, for 4 months from the last dose of cyclophosphamide, and for 5 months from the last dose of bortezomib (whichever is longer) to allow for clearance of any altered sperm:

    • Refrain from donating semen, PLUS either:

      • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier

  • Female Participants

    • Not pregnant or breastfeeding, and at least 1 of the following conditions: applies:

    • Is a PONCBP OR Is a POCBP and must commit to either abstain continuously from heterosexual sexual intercourse (if this is the preferred and usual lifestyle of the participant) or to use 2 methods of reliable birth control simultaneously. This includes 1 highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner’s vasectomy) and 1 additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.

  • Is capable of giving signed informed consent

  • Has an ECOG performance status of 0, 1 or 2, with no deterioration in the 2 weeks before enrollment

  • Has adequate organ function

Exclusion Criteria:

  • Has a previous or current diagnosis of plasma cell dyscrasia with POEMS syndrome or symptomatic MM

  • Has IgM-related AL amyloidosis

  • Has any form of non-AL amyloidosis, including wild type or mutated (ATTR) amyloidosis.

  • Has evidence of significant CV conditions as specified below:

    • 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 ECG changes) or uncorrected valvular disease and not primarily due to AL amyloidosis cardiomyopathy.

    • In-patient 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 a 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) >500 msec. Participants who have a pacemaker may be included regardless of calculated QTc interval

    • Supine systolic blood pressure <90 mm Hg, 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 years, after discussion with GSK medical monitor. The 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 or any other components or excipients or other allergy that, in the opinion of the investigator or GSK medical monitor, contraindicates participation in the study.

  • Has any serious and/or unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant’s safety, obtaining of informed consent, or compliance with the study procedures.

  • Has active infection or active bleeding

  • Has intolerance or contraindications to antiviral prophylaxis.

  • Has known HIV infection, unless the participant can meet all of the following criteria:

    • Established ART for at least 4 weeks and HIV viral load <400 copies/mL within the screening period.

    • CD4+ T-cell (CD4+) counts ≥350 cells/μL.

    • No history of AIDS-defining opportunistic infections within the last 12 months.

  • Has prior therapy for AL amyloidosis or MM, with the exception of 160 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 ALT value >2.5×ULN or >3xULN 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 defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.

  • Has documented presence of HBsAg and/or HBcAb at screening or within 3 months prior to the first dose of study intervention

  • Has a positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention unless the participant can meet the following criteria:

    • RNA test negative.

    • Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 Eligibility last updated 10/21/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20600311

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