Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma, Relapse Multiple Myeloma

In brief

Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy. Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.

Key facts

Study ID

NCT05789303

Run by

University of Chicago

People needed

83

Starts

2023-05-30

Expected to finish

2028-07-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Disease Related
• Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.
• Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).
• Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.
• Prior refractory status to belantamab mafodotin. Concurrent Conditions
• Current corneal epithelial disease except mild changes in corneal epithelium and mild punctate keratopathy.
• Subject must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
• Subject must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect Subject's safety). Subjects with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil the inclusion criteria.
• Subject must not use contact lenses while participating in this study unless instructed by an ophthalmologist.
• Subject must not be simultaneously enrolled in any interventional clinical trial.
• Subject must not have had major surgery ≤ 2 weeks prior to initiating study treatment.
• Subject must not have any evidence of active mucosal or internal bleeding.
• Significant neuropathy (Grades 3-4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment.
• Subject must not have evidence of cardiovascular risk including any of the following:
• Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. Controlled atrial fibrillation is not an exclusion.
• History of myocardial infarction, acute coronary syndromes, coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
• Class III or IV heart failure as defined by the New York Heart Association functional classification system
• Uncontrolled hypertension.
• Subject must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
• Subject must not have an active infection requiring treatment.
• Subject with HIV infection will be excluded unless certain T-cell count, viral load and clinical qualifications are met as confirmed by the study doctor
• Note: consideration must be given to anti-retroviral and prophylactic antimicrobials that may have a drug:drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant.
• Patients with Hepatitis B will be excluded unless certain clinical criteria are met as confirmed by the study doctor.
• Subject must not have positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment unless the subject can meet the following criteria:
• (1) Hepatitis C Ribonucleic acid test is negative (2) Receives successful anti-viral treatment (typically 8 weeks) followed by a negative nucleocapsid ribonucleic acid test after a washout period of at least 4 weeks.

Where it is running

• University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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