🏛️ Verified NIH Record • Updated 2026-07-16
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 (NCT07224672)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: GlaxoSmithKline
🩺 Plain-English Summary (8th-Grade Level)
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 .
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (34 items).
Location: GSK Investigational Site — Rochester, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- GSK Investigational Site — Rochester, Minnesota
- GSK Investigational Site — Westmead, New South Wales
- GSK Investigational Site — Woolloongabba, Queensland
- GSK Investigational Site — Box Hill, Victoria
- GSK Investigational Site — Frankston, Victoria
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.