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Активно (без набиране) Фаза 3 NCT06868667

Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Фаза 3 – широко изпитване преди одобрение
Заболявания: Multiple Myeloma

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Japanese participants with relapsed refractory multiple myeloma.
Кой може да участва
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria. * Previously treated with at least 1 prior line of multiple myeloma (MM) therapy and must have documented disease progression during or after their most recent therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Must have at least 1 aspect of measurable disease, defined as one of the following; 1. Urine M-protein excretion \>=200 mg per 24-hour, or 2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or 3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65). * All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be \<=Grade 1 at the time of enrollment, except for alopecia. * Adequate organ function Exclusion Criteria: * Intolerant to daratumumab. * Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment). * Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. * Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. * Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy. * Prior allogenic stem cell transplant. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. * Corneal epithelial disease
Интервенции
Belantamab mafodotin
DRUG
Daratumumab
DRUG
Bortezomib
DRUG
Dexamethasone
DRUG
Места на провеждане 16
Япония (16)
GSK Investigational Site
Aomori
GSK Investigational Site
Fukuoka
GSK Investigational Site
Himeji
GSK Investigational Site
Kamakura
GSK Investigational Site
Kitakyushu
GSK Investigational Site
Kochi
GSK Investigational Site
Matsuyama
GSK Investigational Site
Nagoya
GSK Investigational Site
Ōgaki
GSK Investigational Site
Okayama
GSK Investigational Site
Osaka
GSK Investigational Site
Shibukawa
GSK Investigational Site
Sunto-gun
GSK Investigational Site
Suwa
GSK Investigational Site
Toyohashi
GSK Investigational Site
Yokohama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.07.2021
Крайна дата
30.06.2028
Регистрационен номер
NCT06868667
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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