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Active (not recruiting) Phase 3 NCT04246047

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

Phase 3 – large-scale trial before approval
Conditions: Multiple Myeloma

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
Who can participate
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.
Interventions
Belantamab mafodotin
DRUG
Daratumumab
DRUG
Bortezomib
DRUG
Dexamethasone
DRUG
Locations 69
Australia (3)
GSK Investigational Site
Benowa , Queensland
GSK Investigational Site
Liverpool , New South Wales
GSK Investigational Site
Wollongong , New South Wales
Belgium (4)
GSK Investigational Site
Brussels
GSK Investigational Site
Brussels
GSK Investigational Site
Ghent
GSK Investigational Site
Roeselare
China (3)
GSK Investigational Site
Beijing
GSK Investigational Site
Jinan
GSK Investigational Site
Shenyang
Greece (3)
GSK Investigational Site
Alexandroupoli
GSK Investigational Site
Athens
GSK Investigational Site
Thessaloniki
Israel (1)
GSK Investigational Site
Tel Aviv
Italy (4)
GSK Investigational Site
Bergamo
GSK Investigational Site
Meldola FC
GSK Investigational Site
Milan
GSK Investigational Site
Siena
Japan (19)
GSK Investigational Site
Aichi
GSK Investigational Site
Aichi
GSK Investigational Site
Aomori
GSK Investigational Site
Ehime
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Gifu
GSK Investigational Site
Gunma
GSK Investigational Site
Hyōgo
GSK Investigational Site
Kanagawa
GSK Investigational Site
Kanagawa
GSK Investigational Site
Kochi
GSK Investigational Site
Nagano
GSK Investigational Site
Okayama
GSK Investigational Site
Osaka
GSK Investigational Site
Osaka
GSK Investigational Site
Shizuoka
Netherlands (2)
GSK Investigational Site
Dordrecht
GSK Investigational Site
Groningen
Poland (8)
GSK Investigational Site
Chorzów
GSK Investigational Site
Krakow
GSK Investigational Site
Lodz
GSK Investigational Site
Lublin
GSK Investigational Site
Lublin
GSK Investigational Site
Nowy Sącz
GSK Investigational Site
Poznan
GSK Investigational Site
Warsaw
Russia (7)
GSK Investigational Site
Moscow
GSK Investigational Site
Nizhny Novgorod
GSK Investigational Site
Novosibirsk
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saratov
GSK Investigational Site
Ufa
South Korea (2)
GSK Investigational Site
Pusan
GSK Investigational Site
Ulsan
Spain (8)
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Cáceres
GSK Investigational Site
Gijón
GSK Investigational Site
L'Hospitalet de Llobrega
GSK Investigational Site
Murcia
GSK Investigational Site
PamplonaNavarra
GSK Investigational Site
Salamanca
United States (5)
GSK Investigational Site
Denver , Colorado
GSK Investigational Site
Fairfield , Ohio
GSK Investigational Site
Kansas City , Kansas
GSK Investigational Site
Tyler , Texas
GSK Investigational Site
Yuma , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.05.2020
Completion date
30.06.2028
Registry ID
NCT04246047
Source
clinicaltrials.gov
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