Official Title
209233: Compassionate Use Individual Request Program for Belantamab Mafodotin in Multiple Myeloma 213304: Expanded Access Program for Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma Who Are Refractory to a Proteasome Inhibitor, and an Immunomodulatory Agent, and an Anti-CD38 Antibody
Brief Summary

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

Detailed Description

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


Individual Patients
Treatment IND/Protocol
Multiple Myeloma

Drug: GSK2857916 anti-BCMA-immunoconjugate
Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks

Eligibility Criteria

Inclusion Criteria:

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years

US GSK Clinical Trials Call Center

GSK Clinical Trials
Study Director

NCT Number
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell