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

STATUS

Recruiting
End date

Jun 16, 2026
participants needed

478
sponsor

GlaxoSmithKline

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Updated on 19 February 2024

See if I qualify

cancer

dexamethasone

measurable disease

multiple myeloma

bortezomib

daratumumab

refractory multiple myeloma

protein concentration

hair thinning

recurrent multiple myeloma

bortezomib/dexamethasone

belantamab mafodotin

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.

Description

Approximately 478 patients will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study.

Details

Condition	Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age	18-100 years
Treatment	Dexamethasone, Daratumumab, Belantamab mafodotin, Bortezomib
Clinical Study Identifier	NCT04246047
Sponsor	GlaxoSmithKline
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 according to the IMWG criteria
	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
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

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