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