Inclusion Criteria:
- Participants are capable of giving signed informed consent which includes compliance
with the requirements and restrictions listed in the Informed Consent Form.
- Male and/or female must be 18 years of age or older, at the time of signing the
informed consent.
- Eastern Cooperative Oncology Group performance status 0-2.
- Participants with histologically or cytologically confirmed diagnosis of multiple
myeloma, as defined in International Myeloma Working Group criteria: 1. Has undergone
autologous stem cell transplant (SCT) or is considered transplant-ineligible; 2. Has
failed at least 2 prior lines of anti-myeloma treatments, including an
immunomodulatory drugs (example [e.g.], lenalidomide or pomalidomide) and a proteasome
inhibitor (e.g., bortezomib, ixazomib or carfilzomib).
- Participants has measurable disease with at least one of the following: Serum
M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per liter [g/L]); Urine
M-protein >=200 milligram per 24 hours (mg/24 hr); and Serum free light chain assay:
Involved free light chain level >=10 milligrams per deciliter (mg/dL) (>=100
milligrams per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or
>1.65).
- Participants with a history of autologous SCT are eligible for study participation
provided the following eligibility criteria are met: 1. Transplant was >100 days prior
to study enrollment, 2. No active infection(s), and 3. Participant meets the remainder
of the eligibility criteria outlined in this protocol.
- Participants with adequate organ system functions as defined follows: Absolute
neutrophil count >=1.0 x 10^9/liter (L); Hemoglobin >=8.0 g/dL (or 4.9 millimoles per
liter); Platelets >= 75 x 10^9/L; Serum bilirubin and aspartate aminotransferase:
Group 1 (normal) serum bilirubin and aspartate aminotransferase <=upper limit of
normal (ULN); Group 2 (moderate) serum bilirubin >1.5-3 x ULN and any aspartate
aminotransferase; alanine aminotransferase <=5 x ULN; Estimated glomerular filtration
rate >=30 milliliter per minute per 1.73 meter square (mL/min/m^2); and left
ventricular ejection fraction by echocardiograms >=45%.
- Main additional inclusion criteria in Group 1 (matched control participants): Matched
to at least one moderate hepatic impaired participant by Baseline albumin levels
(+/-10%) and Baseline weight (+/-20%).
- Female participants: Contraceptive use by women should be consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies. A female participant is eligible to participate if she is not pregnant or
breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP and
using a contraceptive method that is highly effective (with a failure rate of <1% per
year), preferably with low user dependency, during the intervention period and for at
least 9 months after the last dose of study intervention and agrees not to donate eggs
(ova, oocytes) for the purpose of reproduction during this period. The investigator
should evaluate the effectiveness of the contraceptive method in relationship to the
first dose of study intervention. A WOCBP must have a negative highly sensitive serum
pregnancy test within 72 hours of dosing on Cycle 1 Day 1 and agree to use effective
contraception during the study and for 9 months after the last dose of study
medication. The investigator is responsible for review of medical history, menstrual
history, and recent sexual activity to decrease the risk for inclusion of a woman with
an early undetected pregnancy.
- Male participants: Contraceptive use by men should be consistent with local
regulations regarding the methods of contraception for those participating in clinical
studies. Male participants are eligible to participate if they agree to the following
from the time of first dose of study until 6 months after the last dose of study
treatment to allow for clearance of any altered sperm, Plus, any of the following: Be
abstinent from heterosexual intercourse as their preferred and usual lifestyle
(abstinent on a long term and persistent basis) and agree to remain abstinent; or must
agree to use a male condom even if they have undergone a successful vasectomy and
female partner to use an additional highly effective contraceptive method with a
failure rate of <1% per year as when having sexual intercourse with a WOCBP (including
pregnant females).
- Participants with a history of Hepatitis B virus and/or Hepatitis C virus exposure are
eligible under specific conditions.
Exclusion Criteria:
- Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active
polyneuropathy, organomegaly, endocrinopathy, myeloma protein and skin changes,
Waldenstroem Macroglobulinemia.
- Participants had a prior allogeneic SCT.
- Participant has received an investigational drug within 14 days or 5 half-lives,
whichever is shorter, preceding the first dose of study drug. This includes prior
treatment with a monoclonal antibody or prior belantamab mafodotin. The only exception
is emergency use of a short course of systemic corticosteroids (equivalent of
dexamethasone 40 milligrams per day [mg/day] for a maximum of 4 days) before
treatment.
- Participant has received a strong Organic-anion transporting polypeptide (OATP)
inhibitor within 14 days or 5 half-lives, whichever is shorter, preceding the first
dose of study drug.
- Systemic active infection requiring treatment.
- Any unresolved toxicity >=Grade 2 from previous treatment except for alopecia, or
peripheral neuropathy up to Grade 2.
- Plasmapheresis within 7 days prior to the first dose of study drug. Screening
laboratory values must be performed after last plasmapheresis.
- Any major surgery within the last 4 weeks.
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions (including lab abnormalities except hepatic impairment) that could
interfere with participant's safety, obtaining informed consent or compliance to the
study procedures.
- Evidence of active mucosal or internal bleeding.
- Current unstable liver or biliary disease per investigator assessment defined by the
sudden onset of, or clinically relevant changes in: ascites, encephalopathy,
coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, in
the last 14 days prior to the first dose. Participants with cirrhosis are excluded.
Participants with focal lesions due to other causes than underlying multiple myeloma
are excluded.
- Participants with acute hepatitis B virus infection are excluded. Participants with
chronic hepatitis B infection (active or core antibody positive) are only allowed if
the criteria from Organ System Function are fulfilled and if appropriate antiviral
treatment per local guidance (e.g. tenofovir or entecavir) is started before starting
belantamab mafodotin, continues through to completion of belantamab mafodotin therapy
and is not to be stopped unless advised by local hepatology or virology.
- Participants with evidence of hepatitis C virus infection, defined as positive
hepatitis C virus - ribonucleic acid test result at screening or within 3 months prior
to first dose of study treatment, are excluded unless successfully treated prior to
enrollment with a curative 8-12 week antiviral treatment course and the hepatitis C
virus - ribonucleic acid negative status has been confirmed after at least 4 weeks
washout of the antiviral treatment.
- Participants with Gilbert's syndrome.
- Participants with previous or concurrent malignancies other than multiple myeloma,
except: The disease must be considered medically stable for at least 2 years; or the
participant must not be receiving active therapy, other than hormonal therapy for this
disease.
- Evidence of cardiovascular risk including any of the following: Evidence of current
clinically significant untreated arrhythmias, including clinically significant
electrocardiogram abnormalities including second degree (Mobitz Type II) or third
degree atrioventricular block; History of myocardial infarction, acute coronary
syndromes (including unstable angina), coronary angioplasty, or stenting or bypass
grafting within 3 months of Screening; Class III or IV heart failure as defined by the
New York Heart Association functional classification system; History of severe
non-ischemic cardiomyopathy; and Uncontrolled hypertension.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to
drugs chemically related to belantamab mafodotin, or any of the components of the
study treatment.
- Known human immunodeficiency virus infection.
- Current corneal epithelial disease except for mild punctuate keratopathy.
- Participant is a woman who is pregnant or breastfeeding.