Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma

Study Purpose

Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type 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.	Expanded Access
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Individual Patient IND:

INCLUSION CRITERIA:

1. Written informed consent. 2. Diagnosis of RRMM and/or plasma cell dyscrasias and: 1. Has failed 4 prior therapies. 2. Is refractory to and IMID and to a proteasome inhibitor and to an anti CD-38 antibody (alone or in combinations if available) 3. Disease Progression on last therapy. 4. Able to obtain ophthalmic examinations at baseline, before the subsequent 3 treatment cycles and as clinically indicated. 5. Contraception requirements. A. Female Participants: A female patient is eligible to participate if one of the following conditions applies:

I. The patient Is not a woman of childbearing potential (WOCBP)OR II.

The patient Is a WOCBP and using an effective contraceptive method during treatment with belantamab mafodotin and for 4 months after the last dose. The patient must also have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1. Please discuss with GSK physician if the patient is pregnant, breast-feeding or planning to have a baby. B. Male participants with female partners of child-bearing potential are eligible to participate if they agree to use effective contraception during treatment with belantamab mafodotin until 6 months after the last dose.

EXCLUSION CRITERIA:

1. Evidence of Active Bleeding. 2. Currently Active GVHD. 3. Known Hypersensitivity to the active substance or to any of the excipients. 4. Previous progression on belantamab mafodotin. US Expanded Access (group) Protocol:

INCLUSION CRITERIA:

For patients currently receiving BLENREP through the REMS program. 1. Patients currently enrolled in the BLENREP REMS program who have received at least 1 dose of BLENREP. 2. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations. For new patients. 3. New patients diagnosed with RRMM who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. 4. No other treatment options available. 5. Written informed consent can be obtained from the patient or legally authorized representative as per local regulations.

EXCLUSION CRITERIA:

For patients currently receiving BLENREP through the REMS program. 1. Previously progressed on treatment with belantamab mafodotin. 2. Patient is pregnant or breastfeeding. For new patients. 1. Previously progressed on treatment with belantamab mafodotin. 2. Patient is pregnant or breastfeeding

Trial Details

Trial ID: 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.	NCT03763370
Phase 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.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	GlaxoSmithKline
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	GSK Clinical Trials
Principal Investigator Affiliation	GlaxoSmithKline
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Available
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma
Study Website:	View Trial Website

Additional Details

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.

Contact Information

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

GSKClinicalSupportHD@gsk.com

877-379-3718

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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