Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT05064358
Last Updated: 2025-10-07
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
177 participants
INTERVENTIONAL
2022-03-03
2026-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
Belantamab mafodotin
Belantamab mafodotin will be administered.
Cohort 2: Participants receiving belantamab mafodotin at DL 2
Belantamab mafodotin
Belantamab mafodotin will be administered.
Cohort 3: Participants receiving belantamab mafodotin at DL 3
Belantamab mafodotin
Belantamab mafodotin will be administered.
Cohort 4: Participants receiving belantamab mafodotin at DL 4
Belantamab mafodotin
Belantamab mafodotin will be administered.
Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
Belantamab mafodotin
Belantamab mafodotin will be administered.
Interventions
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Belantamab mafodotin
Belantamab mafodotin will be administered.
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
* France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
* Participant has measurable disease per modified IMWG criteria.
* Life expectancy of at least 6 months, in the opinion of the investigator.
* Male and female participants agree to abide by protocol-defined contraceptive requirements.
* Participant is capable of giving signed informed consent.
Exclusion Criteria
* Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
* Evidence of active mucosal or internal bleeding.
* Presence of an active renal condition.
* Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
* Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
* Evidence of cardiovascular risk as per the protocol criteria.
* Pregnant or lactating female.
* Active infection requiring antibiotic, antiviral, or antifungal treatment.
* Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
* Hepatitis B and C will be excluded unless the criteria in protocol can be met.
* Cirrhosis or current unstable liver or biliary disease.
* Alanine aminotransferase (ALT) \>2.5× upper limit of normal (ULN).
* Total Bilirubin \>1.5×ULN.
* Systemic anti-MM therapy within \<=14 days or 5 half-lives, whichever is shorter.
* Systemic therapy with high dose steroids within \<=14 days before the first dose of study treatment.
* Prior allogenic stem cell transplant.
* Prior treatment with a monoclonal antibody \<=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.
* Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.
* Treatment with an antibody-drug conjugate.
* Participant has received any major surgery \<=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.
* Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count \<1.0×10\^9/L, b. Hemoglobin \<8 gram/deciliter (g/dL), c. Platelet count \<50×10\^9/L, d. Spot urine (albumin/creatinine ratio) \>500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2).
* UK specific: a. Absolute neutrophil count \<1.5×10\^9/L, c. Platelet count \<75×10\^9/L
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Chattanooga, Tennessee, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Capital Federal, , Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, , Argentina
GSK Investigational Site
Pilar, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Liverpool, New South Wales, Australia
GSK Investigational Site
Newcastle, New South Wales, Australia
GSK Investigational Site
Woodville, South Australia, Australia
GSK Investigational Site
East Melbourne, Victoria, Australia
GSK Investigational Site
Joinville, , Brazil
GSK Investigational Site
Porto Alegre, , Brazil
GSK Investigational Site
Rio de Janeiro, , Brazil
GSK Investigational Site
Salvador, , Brazil
GSK Investigational Site
São Paulo, , Brazil
GSK Investigational Site
São Paulo, , Brazil
GSK Investigational Site
Oshawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Avignon, , France
GSK Investigational Site
Nice, , France
GSK Investigational Site
Orléans, , France
GSK Investigational Site
Cottbus, , Germany
GSK Investigational Site
Dresden, , Germany
GSK Investigational Site
Greifswald, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Rio Patras, , Greece
GSK Investigational Site
Ahmedabad, , India
GSK Investigational Site
Apex Wellness Hospital, , India
GSK Investigational Site
Hyderabad, , India
GSK Investigational Site
Kolkata, , India
GSK Investigational Site
Kolkata, , India
GSK Investigational Site
M S R Nagar Msrit Post, , India
GSK Investigational Site
Pune, , India
GSK Investigational Site
Sushrut Hospital and Research, , India
GSK Investigational Site
Dublin, , Ireland
GSK Investigational Site
Dublin, , Ireland
GSK Investigational Site
Alessandria, , Italy
GSK Investigational Site
Ascoli Piceno, , Italy
GSK Investigational Site
Cagliari, , Italy
GSK Investigational Site
Ferrara, , Italy
GSK Investigational Site
Genova, , Italy
GSK Investigational Site
Meldola FC, , Italy
GSK Investigational Site
Reggio Emilia, , Italy
GSK Investigational Site
Rimini, , Italy
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Torun, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Wałbrzych, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
Hwasun, , South Korea
GSK Investigational Site
Pusan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Albacete, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Córdoba, , Spain
GSK Investigational Site
Girona, , Spain
GSK Investigational Site
Oviedo, , Spain
GSK Investigational Site
Terrassa - Barcelona, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Bern, , Switzerland
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Tainan City, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Chiang Mai, , Thailand
GSK Investigational Site
Khon Kaen, , Thailand
GSK Investigational Site
Leicester, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Stoke-on-Trent, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-004151-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508213-16
Identifier Type: REGISTRY
Identifier Source: secondary_id
209628
Identifier Type: -
Identifier Source: org_study_id
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