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

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2026-06-19

Brief Summary

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This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Belantamab mafodotin and Bortezomib plus Dexamethasone

Group Type EXPERIMENTAL

Belantamab mafodotin

Intervention Type DRUG

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

Bortezomib

Intervention Type DRUG

Proteasome Inhibitor

Dexamethasone

Intervention Type DRUG

Synthetic glucocorticoid with anti-tumor activity

Daratumumab and Bortezomib plus Dexamethasone

Group Type ACTIVE_COMPARATOR

Daratumumab

Intervention Type DRUG

Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody

Bortezomib

Intervention Type DRUG

Proteasome Inhibitor

Dexamethasone

Intervention Type DRUG

Synthetic glucocorticoid with anti-tumor activity

Interventions

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Belantamab mafodotin

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

Intervention Type DRUG

Daratumumab

Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody

Intervention Type DRUG

Bortezomib

Proteasome Inhibitor

Intervention Type DRUG

Dexamethasone

Synthetic glucocorticoid with anti-tumor activity

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No