Study of Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant and Maintenance for Multiple Myeloma

Exclusion Criteria

• •1. Must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
• •2. Must not have received treatment with a monoclonal antibody within 28 days of receiving the first dose of study drug
• •3. Must not be simultaneously enrolled in any interventional clinical trial
• •4. Must not have amyloidosis or POEMS syndrome.
• •5. Must not be pregnant or lactating.
• •6. Must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, severe 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.
• •7. Must not have any evidence of active mucosal or internal bleeding
• •8. History of an active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill other criteria.
• •9. Participant must not have evidence of cardiovascular risk, as defined in the protocol.
• •10. Must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
• •11. Must not have invasive malignancies other than disease under study, unless the second malignancy has been definitively treated or has been medically stable for at least 2 years and, in the opinion of the principal investigator, will not affect the evaluation of the effects of clinical trial treatment.
• •12. Must not have an active infection requiring antibiotic treatment.
• •13. Any major surgery within the last 4 weeks prior to enrollment.
• •14. Must not have current corneal epithelial disease except mild changes in corneal epithelium
• •15. 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
• •16. Must not have evidence for active hepatitis B infection (i.e. positive hepatitis B surface antigen or nucleic acid-based testing) at screening or within 3 months prior to first dose of belantamab mafodotin.
• •17. Must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
• •18. Must not have evidence of active HIV infection.