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
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 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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) — Up to approximately 32 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 (16)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Aomori | Japan | |
| GSK Investigational Site | Fukuoka | Japan | |
| GSK Investigational Site | Himeji | Japan | |
| GSK Investigational Site | Kamakura | Japan | |
| GSK Investigational Site | Kitakyushu | Japan | |
| GSK Investigational Site | Kochi | Japan | |
| GSK Investigational Site | Matsuyama | Japan | |
| GSK Investigational Site | Nagoya | Japan | |
| GSK Investigational Site | Okayama | Japan | |
| GSK Investigational Site | Osaka | Japan | |
| GSK Investigational Site | Ōgaki | Japan | |
| GSK Investigational Site | Shibukawa | Japan | |
| GSK Investigational Site | Sunto-gun | Japan | |
| GSK Investigational Site | Suwa | Japan | |
| GSK Investigational Site | Toyohashi | Japan | |
| GSK Investigational Site | Yokohama | Japan |
On this site
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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 NCT06868667 on ClinicalTrials.gov ↗ ← All trials in Japan