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

NCT06868654 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: 207503-CHN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

China Subpopulation; Belantamab mafodotin; Relapsed/refractory multiple myeloma; Daratumumab; Bortezomib; Dexamethasone; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.

  Up to approximately 32 months

Secondary Outcomes (22)

• Overall Survival (OS)

  Up to 255 weeks

• Duration of Response (DoR)

  Up to 255 weeks

• Minimal Residual Disease (MRD) Negativity Rate

  Up to 255 weeks

• Complete Response Rate (CRR)

  Up to 255 weeks

• Overall Response Rate (ORR)

  Up to 255 weeks

Study Arms (2)

Belantamab mafodotin and Bortezomib plus Dexamethasone

EXPERIMENTAL

Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Dexamethasone

Daratumumab and Bortezomib plus Dexamethasone

ACTIVE COMPARATOR

Drug: Daratumumab; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Belantamab mafodotin DRUG

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

Belantamab mafodotin and Bortezomib plus Dexamethasone

Daratumumab DRUG

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

Daratumumab and Bortezomib plus Dexamethasone

Bortezomib DRUG

Proteasome Inhibitor

Belantamab mafodotin and Bortezomib plus Dexamethasone; Daratumumab and Bortezomib plus Dexamethasone

Dexamethasone DRUG

Synthetic glucocorticoid with anti-tumor activity

Belantamab mafodotin and Bortezomib plus Dexamethasone; Daratumumab and Bortezomib plus Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Beijing, China

Location

GSK Investigational Site

Changchun, China

Location

GSK Investigational Site

Guangzhou, China

Location

GSK Investigational Site

Hangzhou, China

Location

GSK Investigational Site

Jinan, China

Location

GSK Investigational Site

Nanjing, China

Location

GSK Investigational Site

Shenyang, China

Location

GSK Investigational Site

Suzhou, China

Location

GSK Investigational Site

Tianjin, China

Location

GSK Investigational Site

Wuhan, China

Location

GSK Investigational Site

Zhengzhou, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; daratumumab; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: July 28, 2021
• Primary Completion: April 3, 2024
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)