Phase II MRD-guided comparison of reduced versus standard-dose belantamab mafodotin plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma

Prior treatment

• Active plasma cell leukemia, AL amyloidosis, POEMS syndrome, prior allogeneic stem cell transplant, or active graft versus host disease
• History of venous thromboembolism within 3 months prior to enrollment
• Recent anti multiple myeloma therapy or investigational treatment prior to the first dose of study treatment, as defined in the protocol
• Plasmapheresis within 7 days prior to the first dose of study treatment
• Prior treatment with belantamab mafodotin or pomalidomide in any treatment line
• Major surgery within 4 weeks prior to enrollment

Other illness

• Cirrhosis or unstable hepatic or biliary disease, as assessed by the investigator
• Active, uncontrolled bacterial, viral, or fungal infection
• Known HIV infection, unless meeting protocol defined criteria for controlled infection
• Active hepatitis B or hepatitis C infection, unless meeting protocol defined criteria for controlled infection
• Severe or unstable renal disease that could compromise participant safety
• Active corneal disease, except for mild punctate keratopathy
• Any serious or unstable medical or psychiatric condition that could interfere with participant safety, informed consent, or compliance with study procedures
• Clinically significant cardiovascular disease, including uncontrolled arrhythmias, recent myocardial infarction or acute coronary syndrome, NYHA class III–IV heart failure, or uncontrolled hypertension
• Other active malignancy, except for malignancies considered medically stable or not requiring active systemic therapy, as defined in the protocol
• Known hypersensitivity to belantamab mafodotin or any component of the study treatment
• Evidence of active mucosal or internal bleeding

Other

• Contraindication or intolerance to required antiviral prophylaxis
• Ongoing peripheral neuropathy or neuropathic pain of Grade ≥3
• Contraindication to required antithrombotic prophylaxis
• Pregnant or breastfeeding women

• Adult patients (≥18 years of age) with a confirmed diagnosis of multiple myeloma according to IMWG criteria.
• Relapsed or refractory multiple myeloma, previously treated with at least one prior line of therapy, including a lenalidomide containing regimen, with documented disease progression during or after the most recent therapy.
• Measurable disease as defined by IMWG criteria
• ECOG performance status 0–2
• Prior autologous stem cell transplant (autoSCT) or transplant ineligible, with autoSCT performed >100 days prior to first dose, if applicable.
• Adequate organ function, including hematologic, hepatic and renal function, as defined in the protocol.
• Resolution of prior treatment related toxicities to Grade ≤1, except for alopecia and Grade ≤2 peripheral neuropathy
• Ability to provide written informed consent and comply with protocol requirements