Official Title
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

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.
US patients who have been treated through the REMS program are eligible to enroll in this
program.

Available
Individual Patients
Treatment IND/Protocol
Multiple Myeloma

Drug: Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate

Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Contacts

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

GSK Clinical Trials, Study Director
GlaxoSmithKline

GlaxoSmithKline
NCT Number
Keywords
213304
belantamab mafodotin
Expanded Access Program
Multiple myeloma
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell
Immunoconjugates