A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)

GlaxoSmithKline77 个研究点分布在 12 个国家目标入组 177 人开始时间: 2022年3月3日最近更新: 2026年5月5日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 177
试验地点: 77
主要终点: Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

盲法说明

It is an open label study

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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
•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.

排除标准

•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