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 https://gsk-cu-portal.idea-point.com.

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 States.

Available
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
All
Eligibility Age
Minimum: 18 Years
Contacts

US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

GSK Clinical Trials
Study Director
GlaxoSmithKline

GlaxoSmithKline
NCT Number
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell
Immunoconjugates