Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT04246047
This Phase 3, open-label trial assesses the safety and efficacy of belantamab mafodotin with bortezomib/dexamethasone versus daratumumab with bortezomib/dexamethasone in relapsed/refractory multiple myeloma. Eligible participants must have a confirmed diagnosis, prior treatment, measurable disease, ECOG status 0-2, and adequate organ function. Interventions include BCMA and CD-38 targeting drugs.
Patient Parameters
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Program Overview
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 Criteria
Inclusion Criteria
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Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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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).
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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.
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 85364 | Yuma | Arizona |
| GSK Investigational Site | 80218 | Denver | Colorado |
| GSK Investigational Site | 66205 | Kansas City | Kansas |
| GSK Investigational Site | 45242 | Fairfield | Ohio |
| GSK Investigational Site | 75702 | Tyler | Texas |
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