Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Individual Patient IND:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|GSK Clinical Trials|
|Principal Investigator Affiliation||GlaxoSmithKline|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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. US patients who have been treated through the REMS program are eligible to enroll in this program.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
US GSK Clinical Trials Call Center
For additional contact information, you can also visit the trial on clinicaltrials.gov.