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Clinical Trials in Australia / NCT04246047
Active, not recruiting Phase 3

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

NCT04246047 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2020-05-07
Last updated
2026-04-23

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Belantamab mafodotin →Daratumumab →Bortezomib →Dexamethasone →

Belantamab mafodotin: Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

Daratumumab: Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody

Bortezomib: Proteasome Inhibitor

Dexamethasone: Synthetic glucocorticoid with anti-tumor activity

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
GSK Investigational Site Yuma Arizona
GSK Investigational Site Denver Colorado
GSK Investigational Site Kansas City Kansas
GSK Investigational Site Fairfield Ohio
GSK Investigational Site Tyler Texas
GSK Investigational Site Liverpool New South Wales
GSK Investigational Site Wollongong New South Wales
GSK Investigational Site Benowa Queensland
GSK Investigational Site Brussels Belgium
GSK Investigational Site Brussels Belgium
GSK Investigational Site Ghent Belgium
GSK Investigational Site Roeselare Belgium
GSK Investigational Site Beijing China
GSK Investigational Site Jinan China
GSK Investigational Site Shenyang China
GSK Investigational Site Alexandroupoli Greece
GSK Investigational Site Athens Greece
GSK Investigational Site Thessaloniki Greece
GSK Investigational Site Tel Aviv Israel
GSK Investigational Site Bergamo Italy
GSK Investigational Site Meldola FC Italy
GSK Investigational Site Milan Italy
GSK Investigational Site Siena Italy
GSK Investigational Site Aichi Japan
GSK Investigational Site Aichi Japan
GSK Investigational Site Aomori Japan
GSK Investigational Site Ehime Japan
GSK Investigational Site Fukuoka Japan
GSK Investigational Site Fukuoka Japan
GSK Investigational Site Fukuoka Japan
GSK Investigational Site Fukuoka Japan
GSK Investigational Site Gifu Japan
GSK Investigational Site Gunma Japan
GSK Investigational Site Hyōgo Japan
GSK Investigational Site Kanagawa Japan
GSK Investigational Site Kanagawa Japan
GSK Investigational Site Kochi Japan
GSK Investigational Site Nagano Japan
GSK Investigational Site Okayama Japan
GSK Investigational Site Osaka Japan

+ 29 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

More GlaxoSmithKline trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04246047 on ClinicalTrials.gov ↗ ← All trials in Australia