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Tests treatment safety and results for Amyloidosis
Official title 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
ClinicalTrials.gov ID: NCT07224672
What this study is testing
What is Belantamab mafodotin?
Belantamab mafodotin is an investigational medicine, being studied as a potential treatment for amyloidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable clonal disease as defined by at least 1 of the following:
You likely can't join if
- Has a previous or current diagnosis of plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- Supine systolic blood pressure \ 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...
- 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 \ =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 treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Westmead, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Box Hill, Victoria, Australia
- Frankston, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Westmead, New South Wales, Australia; Woolloongabba, Queensland, Australia; Box Hill, Victoria, Australia; Frankston, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.