Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma

NCT07614360 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 3009482026-526724-43
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.

Conditions

Multiple Myeloma

Keywords

Belantamab mafodotin; Bortezomib; Corneal events; Dexamethasone; DREAMM-16; Proteasome inhibitor; Immunomodulatory agent

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with grade greater than or equal to (>=)3 corneal events assessed by keratopathy visual acuity (KVA) scale

  KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.

  Up to approximately 4.5 years

• Percentage of participants with grade >=3 corneal events assessed by KVA scale up to Month 6

  KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.

  Up to Month 6

• Percentage of Participants With Grade >=3 Corneal Events Assessed by KVA scale from 6 to 12 months

  KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events. Data will be presented for the total number of participants with corneal events in each study group during 6 to 12 months.

  From 6 to 12 months

Secondary Outcomes (18)

• Incidence of corneal events as assessed by KVA scale accounting for time on study treatment

  Up to approximately 4.5 years

• Percentage of participants with corneal events as assessed by KVA scale

  Up to approximately 4.5 years

• Number of recurrences of corneal events as assessed by KVA scale

  Up to approximately 4.5 years

• Percentage of participants with post-baseline Best corrected visual acuity of 20/50, 20/100, 20/200

  Up to approximately 4.5 years

• Number of participants with ocular adverse events and adverse events of special interest by National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) Version 6.0

  Up to approximately 4.5 years

Study Arms (3)

Participants receiving Belantamab mafodotin dosing regimen 1 + Bortezomib + Dexamethasone

EXPERIMENTAL

Participants will receive dosing regimen 1 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone

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

Participants receiving Belantamab mafodotin dosing regimen 2 + Bortezomib + Dexamethasone

EXPERIMENTAL

Participants will receive dosing regimen 2 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone.

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

Participants receiving Belantamab mafodotin dosing regimen 3 + Bortezomib + Dexamethasone

EXPERIMENTAL

Participants will receive dosing regimen 3 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone.

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

Interventions

Belantamab mafodotin DRUG

Belantamab mafodotin will be administered

Participants receiving Belantamab mafodotin dosing regimen 1 + Bortezomib + Dexamethasone; Participants receiving Belantamab mafodotin dosing regimen 2 + Bortezomib + Dexamethasone; Participants receiving Belantamab mafodotin dosing regimen 3 + Bortezomib + Dexamethasone

Dexamethasone DRUG

Dexamethasone will be administered.

Participants receiving Belantamab mafodotin dosing regimen 1 + Bortezomib + Dexamethasone; Participants receiving Belantamab mafodotin dosing regimen 2 + Bortezomib + Dexamethasone; Participants receiving Belantamab mafodotin dosing regimen 3 + Bortezomib + Dexamethasone

Bortezomib DRUG

Bortezomib will be administered

Participants receiving Belantamab mafodotin dosing regimen 1 + Bortezomib + Dexamethasone; Participants receiving Belantamab mafodotin dosing regimen 2 + Bortezomib + Dexamethasone; Participants receiving Belantamab mafodotin dosing regimen 3 + Bortezomib + Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).
• Has histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by the IMWG.
• Previously treated with at least 2 prior lines of MM therapy, including a proteasome inhibitor and an immunomodulatory agent.
• Has at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as at least 1 of the following:
• Urine M-protein excretion \>=200 milligrams (mg)/24 hours (\>=0.2 grams \[g\]/24 hours)
• Serum M-protein concentration \>=0.5 grams per deciliter (g/dL) (\>=5.0 g/L)
• Serum free light chain (FLC) assay: involved FLC level \>=10 milligrams per deciliter (mg/dL) (\>=100 mg/L) and an abnormal serum FLC ratio (less than \[\<\] 0.26 or greater than \[\>\] 1.65).
• Participants with a history of autologous stem cell transplants are eligible for study participation provided the following eligibility criteria are met:
• Transplant was \> 100 days prior to study enrollment
• No active infection(s)
• Participant meets the remainder of the eligibility criteria
• All prior treatment-related toxicities (defined by NCI-CTCAE version \[v\] 6.0) must be Grade less than or equal to (\<=)1 at the time of treatment assignment, except for alopecia (any grade), neuropathy (Grade \<=2), or endocrinopathy managed with replacement therapy (any grade).
• Is willing to use adequate contraception male and female participants. Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of belantamab mafodotin and 5 months after the last dose of bortezomib, whichever is longest, to allow for clearance of any altered sperm:
• Refrain from donating fresh unwashed semen PLUS either

You may not qualify if:

• Intolerant to bortezomib
• Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \>5%)
• Has previous or concurrent invasive malignancy other than Multiple myeloma (MM), except:
• The disease must be considered medically stable for at least 2 years; or
• The participant must not be receiving active therapy, other than hormonal therapy for this disease.
• Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
• Evidence of active mucosal or internal bleeding.
• Active infection requiring treatment
• Any major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery after consultation with Medical Monitor.
• Active or history of venous and arterial thromboembolism within the past 3 months.
• Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
• Current corneal epithelial disease except for mild punctate keratopathy
• Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
• Participants after prior allogeneic stem cell transplant.
• Has received prior belantamab mafodotin therapy.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; Dexamethasone; Bortezomib

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)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

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

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 11, 2031
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share