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

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT04246047

Run by

GlaxoSmithKline

People needed

494

Starts

2020-05-07

Expected to finish

2028-06-30

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Urine M-protein excretion >=200 mg per 24-hour, or
• Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or
• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Kansas City, Kansas, United States
• GSK Investigational Site — Fairfield, Ohio, United States
• GSK Investigational Site — Tyler, Texas, United States
• GSK Investigational Site — Liverpool, New South Wales, Australia
• GSK Investigational Site — Wollongong, New South Wales, Australia
• GSK Investigational Site — Benowa, Queensland, Australia
• 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 — Yuma, Arizona, United States

Full record on ClinicalTrials.gov

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