Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma. You can access GSK's Compassionate Use (Expanded Access) Request Portal via https://gsk-cu-portal.idea-point.com.
belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds specifically to B-Cell Maturation Antigen. This program is intended to provide access to belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). Patients considering this access program should have no other therapeutic option, and not eligible for other clinical trials. Compassionate use program (209233): Additional Criteria: patients must have failed at least three lines of above stated prior therapy and should also be ineligible for all currently approved standard of care for 4L+ MM in the requesting country. The Expanded Access program (213304) is currently only available in the United States only. The Individual Patient program (209233) is available in countries other than the United States.
Drug: Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate
Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks
Adequate organ system functions.
Criteria for Determining Adequate Organ System Function:
Lab Parameter -- Laboratory Values Absolute Neutrophil count -- (ANC) / ≥ 1.0 X 109/L
Hemoglobin -- ≥ 7.0 g/dL Platelets -- ≥ 50 X 109/L Total bilirubin -- ≤1.5X ULN (Isolated
bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
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