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

• Status: Active, not recruiting
• Trial end date: 2026-08-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone acetate

Criteria

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.