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

• Status: Not yet recruiting
• Trial end date: 2024-08-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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-MM 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).

• 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.

• Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy.

• 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 after consultation with the GSK medical director.

• 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 <8×10^9/L, 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).