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
NCT ID: NCT06868667
Last Updated: 2025-05-09
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
24 participants
INTERVENTIONAL
2021-07-28
2026-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Belantamab mafodotin and Bortezomib plus Dexamethasone
Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate.
Bortezomib
Proteasome Inhibitor.
Dexamethasone
Synthetic glucocorticoid with anti-tumor activity.
Daratumumab and Bortezomib plus Dexamethasone
Daratumumab
Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody.
Bortezomib
Proteasome Inhibitor.
Dexamethasone
Synthetic glucocorticoid with anti-tumor activity.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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207503-JPN
Identifier Type: -
Identifier Source: org_study_id
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