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Active, not recruiting Phase 3

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

NCT06868667 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2021-07-28
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 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

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)

  • 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)

FacilityCityRegionStatus
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
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 NCT06868667 on ClinicalTrials.gov ↗ ← All trials in Japan