Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free Survival (PFS) — Up to approximately 41 months
PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
Trial sites (69)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
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 Italy