Phase
Condition
Multiple Myeloma
Cancer/tumors
Bone Neoplasm
Treatment
Belamaf
Bela
Belantamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants at the time of signing the Informed Consent Form (ICF) are at least 18years old or are of the legal age of consent in the jurisdiction in which the studyis taking place.
Participants who have histologically or cytologically confirmed diagnosis ofMultiple Myeloma (MM), as defined by the international myeloma working group (IMWG).
- Participants who have received at least 3 prior lines of anti-myelomatreatments, and have already received an immunomodulating agent, a proteasomeinhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable) andhave confirmed progression on or following the last line of treatment.
- Participants with a history of Autologous stem cell transplant (ASCT) are eligiblefor study participation provided the following eligibility criteria are met:
transplant was greater than (>)100 days prior to screening.
no active infection(s)
Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.
Measurable disease defined as at least ONE of the following:
Serum M-protein concentration greater than (>=) 0.5 gram (g)/ deciliter (dL) (>=5 gram/liter [g/L])
Urine M-protein excretion >=200 mg/24 hours (>=0.2 g/24 hours)
Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100milligrams per liter [mg/L]) and an abnormal serum FLC ratio (less than [<]0.26or >1.65)
Have adequate organ system function as defined by the laboratory assessments.
All prior treatment-related toxicities (defined by National Cancer Institute-CommonToxicity Criteria for Adverse Events [NCI-CTCAE], v5.0, 2017) must be Grade <=1 atthe time of screening except for alopecia (any grade), neuropathy (Grade <=2), orendocrinopathy managed with replacement therapy (any grade).
Participants or Legally authorized representative (LAR) capable of giving signedinformed consent, which includes compliance with the requirements and restrictionslisted in the ICF and in this protocol.
Exclusion
Exclusion Criteria:
Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy,organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome,primary plasma cell leukemia.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or otherconditions (including lab abnormalities) that could interfere with participant'ssafety, obtaining informed consent, or compliance with study procedures.
Participant is exhibiting signs of meningeal or central nervous system involvementwith MM.
Current corneal epithelial disease except nonconfluent Superficial punctatekeratitis (SPK).
Has cirrhosis or current unstable liver or biliary disease per investigatorassessment defined by the presence of ascites, encephalopathy, coagulopathy,hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
Presence of malignancies other than disease under study are excluded, except for anyother malignancy from which the participant has been disease-free for more than 2years and, in the opinion of the Principal investigator (PI) and GlaxoSmithKline (GSK) Medical Director, will not affect the evaluation of the effects of thisclinical trial treatment on the currently targeted malignancy (MM).
Evidence of cardiovascular risk
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugschemically related to belantamab / belantamab mafodotin or any of the components ofthe study treatment. History of severe hypersensitivity to other Monoclonalantibodies (mAbs).
Active infection requiring antibiotic, antiviral, or antifungal treatment.
Known Human immunodeficiency virus (HIV) infection, unless the participant can meetspecific criteria.
Recent history (within the past 6 months) of acute diverticulitis, inflammatorybowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
Participants with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will beexcluded unless specific criteria can be met
Presence of active renal condition (infection, requirement for dialysis or any othercondition that could affect participant's safety). Participants with isolatedproteinuria resulting from MM are eligible
Part 1: Refractory to belantamab mafodotin (confirmed PD as per IMWG criteria whileon belantamab mafodotin therapy or within 60 days of completing that treatment).Prior belantamab mafodotin is allowed if it was discontinued due to toxicity whichsubsequently resolved.
Part 2: Prior belantamab mafodotin therapy is not allowed. Prior treatment withother anti-BCMA directed agents is allowed provided there is at least a 6-monthwashout period from completion of prior anti-BCMA therapy to start of study therapy.
Prior radiotherapy within 2 weeks of start of study therapy.
Plasmapheresis within 7 days prior to the first dose of study drug.
Prior allogeneic transplant is prohibited.
Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first doseor has not recovered fully from surgery.
Prior treatment with a mAb within 30 days of receiving the first dose of studydrugs, or treatment with an investigational agent or approved systemic anti-myelomatherapy (including systemic steroids) within 14 days or 5 half-lives of receivingthe first dose of study drugs, whichever is longer.
Part 1: Has received transfusion of blood products (including platelets or red bloodcells) or administration of colony stimulating factors (including Granulocyte colonystimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GMCSF), recombinant erythropoietin) or any thrombopoietin receptor agonists within 2 weeks before the first dose of study drug.
Participants must not receive live/live attenuated vaccines within 30 days prior tofirst dose of study treatment or whilst receiving belantamab for at least 70 daysfollowing last study treatment.
Known, current drug or alcohol abuse.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling,or child) who is investigational site or Sponsor staff directly involved with thistrial, unless prospective Independent Review Board (IRB) approval (by chair ordesignee) is allowing exception to this criterion for a specific participant.
Study Design
Connect with a study center
GSK Investigational Site
Ciudadela, B1702
ArgentinaCompleted
GSK Investigational Site
Viedma, R8500ACE
ArgentinaActive - Recruiting
GSK Investigational Site
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
GSK Investigational Site
Nedlands, Western Australia 6009
AustraliaCompleted
GSK Investigational Site
Joinville, 89201-260
BrazilActive - Recruiting
GSK Investigational Site
SAo Paulo, 04537-080
BrazilActive - Recruiting
GSK Investigational Site
Salvador, 41253-190
BrazilActive - Recruiting
GSK Investigational Site
São Paulo, 04537-080
BrazilSite Not Available
GSK Investigational Site
Aomori, 030-8553
JapanActive - Recruiting
GSK Investigational Site
Chiba, 277-8577
JapanActive - Recruiting
GSK Investigational Site
Osaka, 545-8586
JapanCompleted
GSK Investigational Site
Tokyo, 105-8471
JapanActive - Recruiting
GSK Investigational Site
Seoul, 137-701
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, Korea, 137-701
Korea, Republic ofSite Not Available
GSK Investigational Site
Mexico City, 01330
MexicoSite Not Available
GSK Investigational Site
Gdansk, 80-214
PolandSite Not Available
GSK Investigational Site
Lublin, 20-081
PolandActive - Recruiting
GSK Investigational Site
Changhua, 500
TaiwanActive - Recruiting
GSK Investigational Site
Taipei, 100
TaiwanActive - Recruiting
GSK Investigational Site
Istanbul, 34010
TurkeySite Not Available
GSK Investigational Site
Kayseri, 38039
TurkeySite Not Available
GSK Investigational Site
Leicester, LE1 5WW
United KingdomActive - Recruiting
GSK Investigational Site
Oxford, OX3 7LE
United KingdomActive - Recruiting
GSK Investigational Site
Oxford., OX3 7LE
United KingdomSite Not Available
GSK Investigational Site
Plymouth, PL6 8DH
United KingdomActive - Recruiting
GSK Investigational Site
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
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