Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

NCT05064358 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2096282021-004151-162023-508213-16
• Study Type: interventional
• Target: 177
• Locations: 18 countries
• Sites: 77

Brief Summary

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Conditions

Multiple Myeloma

Keywords

Antibody drug conjugate; Belantamab mafodotin; BLENREP; DREAMM14; GSK2857916; Alternative dosing; Relapsed or refractory multiple myeloma; RRMM

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale

  The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.

  Up to 29.5 months

Secondary Outcomes (30)

• Number of Participants With Corneal Events up to Week 16

  Up to week 16

• Incidence Rate of Corneal Events by Grade (KVA Scale)

  Up to 152 weeks

• Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade

  Up to 152 weeks

• Median Duration of All the Dose Delays

  Up to 152 weeks

• Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events

  Up to 152 weeks

Study Arms (5)

Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1

EXPERIMENTAL

Drug: Belantamab mafodotin

Cohort 2: Participants receiving belantamab mafodotin at DL 2

EXPERIMENTAL

Drug: Belantamab mafodotin

Cohort 3: Participants receiving belantamab mafodotin at DL 3

EXPERIMENTAL

Drug: Belantamab mafodotin

Cohort 4: Participants receiving belantamab mafodotin at DL 4

EXPERIMENTAL

Drug: Belantamab mafodotin

Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification

EXPERIMENTAL

Drug: Belantamab mafodotin

Interventions

Belantamab mafodotin DRUG

Belantamab mafodotin will be administered.

Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1; Cohort 2: Participants receiving belantamab mafodotin at DL 2; Cohort 3: Participants receiving belantamab mafodotin at DL 3; Cohort 4: Participants receiving belantamab mafodotin at DL 4; Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification

Eligibility Criteria

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

You may qualify if:

• Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
• France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
• Participant has measurable disease per modified IMWG criteria.
• Life expectancy of at least 6 months, in the opinion of the investigator.
• Male and female participants agree to abide by protocol-defined contraceptive requirements.
• Participant is capable of giving signed informed consent.

You may not qualify if:

• Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
• Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
• Evidence of active mucosal or internal bleeding.
• Presence of an active renal condition.
• Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
• Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
• Evidence of cardiovascular risk as per the protocol criteria.
• Pregnant or lactating female.
• Active infection requiring antibiotic, antiviral, or antifungal treatment.
• Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
• Hepatitis B and C will be excluded unless the criteria in protocol can be met.
• Cirrhosis or current unstable liver or biliary disease.
• Alanine aminotransferase (ALT) \>2.5× upper limit of normal (ULN).
• Total Bilirubin \>1.5×ULN.
• Systemic anti-MM therapy within \<=14 days or 5 half-lives, whichever is shorter.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (77)

GSK Investigational Site

West Palm Beach, Florida, 33401, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64114, United States

Location

GSK Investigational Site

New York, New York, 10065, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37404, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Houston, Texas, 77090, United States

Location

GSK Investigational Site

Buenos Aires, C1181ACH, Argentina

Location

GSK Investigational Site

Capital Federal, C1426ANZ, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1414, Argentina

Location

GSK Investigational Site

Pilar, B1629AHJ, Argentina

Location

GSK Investigational Site

Rosario, S2002, Argentina

Location

GSK Investigational Site

Liverpool, New South Wales, 2170, Australia

Location

GSK Investigational Site

Newcastle, New South Wales, 2298, Australia

Location

GSK Investigational Site

Woodville, South Australia, 5011, Australia

Location

GSK Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

GSK Investigational Site

Joinville, 89201-260, Brazil

Location

GSK Investigational Site

Porto Alegre, 90850-170, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 22271-110, Brazil

Location

GSK Investigational Site

Salvador, 41253-190, Brazil

Location

GSK Investigational Site

São Paulo, 01236-030, Brazil

Location

GSK Investigational Site

São Paulo, 04537-080, Brazil

Location

GSK Investigational Site

Montreal, Quebec, H4J 1C5, Canada

Location

GSK Investigational Site

Avignon, 84902, France

Location

GSK Investigational Site

Nice, 06189, France

Location

GSK Investigational Site

Orléans, 45100, France

Location

GSK Investigational Site

Cottbus, 03048, Germany

Location

GSK Investigational Site

Dresden, 01307, Germany

Location

GSK Investigational Site

Greifswald, 17475, Germany

Location

GSK Investigational Site

Hamburg, 22763, Germany

Location

GSK Investigational Site

Athens, 106 76, Greece

Location

GSK Investigational Site

Athens, 11528, Greece

Location

GSK Investigational Site

Athens, 12462, Greece

Location

GSK Investigational Site

Rio Patras, 26504, Greece

Location

GSK Investigational Site

Dublin, 8, Ireland

Location

GSK Investigational Site

Dublin, D09 V2N0, Ireland

Location

GSK Investigational Site

Alessandria, 15121, Italy

Location

GSK Investigational Site

Ascoli Piceno, 63100, Italy

Location

GSK Investigational Site

Ferrara, 44124, Italy

Location

GSK Investigational Site

Genova, 16132, Italy

Location

GSK Investigational Site

Meldola FC, 47014, Italy

Location

GSK Investigational Site

Reggio Emilia, 42123, Italy

Location

GSK Investigational Site

Rimini, 47900, Italy

Location

GSK Investigational Site

Mexico City, 03100, Mexico

Location

GSK Investigational Site

Mexico City, 03720, Mexico

Location

GSK Investigational Site

Bydgoszcz, 85-168, Poland

Location

GSK Investigational Site

Gdansk, 80-214, Poland

Location

GSK Investigational Site

Katowice, 40-519, Poland

Location

GSK Investigational Site

Lublin, 20-081, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Torun, 87-100, Poland

Location

GSK Investigational Site

Warsaw, 02-781, Poland

Location

GSK Investigational Site

Wałbrzych, 58-309, Poland

Location

GSK Investigational Site

Wroclaw, 50-367, Poland

Location

GSK Investigational Site

Hwasun, 58128, South Korea

Location

GSK Investigational Site

Pusan, 49241, South Korea

Location

GSK Investigational Site

Seoul, 03080, South Korea

Location

GSK Investigational Site

Seoul, 06591, South Korea

Location

GSK Investigational Site

Albacete, 02006, Spain

Location

GSK Investigational Site

Barcelona, 08026, Spain

Location

GSK Investigational Site

Córdoba, 140044, Spain

Location

GSK Investigational Site

Girona, 17007, Spain

Location

GSK Investigational Site

Oviedo, 33011, Spain

Location

GSK Investigational Site

Terrassa - Barcelona, 08221, Spain

Location

GSK Investigational Site

Valencia, 46010, Spain

Location

GSK Investigational Site

Bern, 3010, Switzerland

Location

GSK Investigational Site

Taichung, 404, Taiwan

Location

GSK Investigational Site

Taichung, 40705, Taiwan

Location

GSK Investigational Site

Tainan, 704, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

GSK Investigational Site

Bangkok, 10210, Thailand

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Leicester, LE1 5WW, United Kingdom

Location

GSK Investigational Site

London, W12 0HS, United Kingdom

Location

GSK Investigational Site

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

belantamab mafodotin

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is an open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Belantamab mafodotin will be administered using various dosing regimens.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: March 3, 2022
• Primary Completion: August 19, 2024
• Study Completion: February 10, 2026
• Last Updated: May 5, 2026
• Results First Posted: October 7, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); GB (3); FR (3); GR (4); AR (5); BR (6); IE (2); CH (1); AU (4); TW (5); KR (4); DE (4); PL (9); TH (4); CA (1); ME (2); ES (7); IT (7)