Phase 2 study of belantamab mafodotin in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma

You likely can't join if

• 1) Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. 2) Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain 3) Prior treatment with anti-BCMA therapy 4) Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic antimyeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter 5) Plasmapheresis within 7 days prior to the first dose of study drug 6) Has received radiotherapy to a large pelvic area (check with sponsor). Bridging radiotherapy otherwise is allowed. 7) Prior allogenic stem cell transplant. 8) Any major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery after consultation with medical monitor. 9) Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant’s safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria given in inclusion criterium number 9. 10) Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant’s safety, obtaining informed consent or compliance to the study procedures 11) Evidence of active mucosal or internal bleeding 12) Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice 13) Previous or concurrent malignancies other than multiple myeloma, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. 14) Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block 15) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months before screening 16) Class III or IV heart failure as defined by the New York Heart Association functional classification system 17) Uncontrolled hypertension 18) Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, bortezomib, boron or mannitol or any other components of the study treatment 19) Active infection requiring treatment 20) Known HIV infection 21) Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HbcAb), at screening or within 3 months prior to first dose of study treatment. 22) Current corneal epithelial disease except for mild punctate keratopathy 23) Intolerance or contraindications to anti-viral prophylaxis 24) Symptomatic AL amyloidosis or active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes)