Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

Study Purpose

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).

- 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.

- Participant meets country-specific inclusion criteria described in the protocol.

Exclusion Criteria:

- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.

- 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

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.	NCT05064358
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.	Phase 2
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	Recruiting
Countries	Argentina, Australia, Brazil, Canada, France, Germany, Greece, India, Ireland, Italy, Korea, Republic of, Mexico, Poland, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Arms & Interventions

Arms

Experimental: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1

Experimental: Cohort 2: Participants receiving belantamab mafodotin at DL 2

Experimental: Cohort 3: Participants receiving belantamab mafodotin at DL 3

Experimental: Cohort 4: Participants receiving belantamab mafodotin at DL 4

Experimental: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification

Interventions

Drug: - Belantamab mafodotin

Belantamab mafodotin will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

GSK Investigational Site, New Port Richey, Florida

Status

Recruiting

Address

GSK Investigational Site

New Port Richey, Florida, 34655

Site Contact

US GSK Clinical Trials Call Center

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