A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment

NCT07609706 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 3082472026-526725-18-00
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the clinical trial is to collect safety data and information on how the body processes BVd in people with multiple myeloma (MM) who have moderate liver problems, compared with similar participants who have normal liver function. It also compares how liver problems affect the body's handling of belantamab mafodotin and uses the results to help set safe and appropriate dosing guidance for MM participants with moderate liver problems.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Hepatic Impairment; Bortezomib; Dexamethasone; Belantamab mafodotin

Outcome Measures

Primary Outcomes (9)

• Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC 0-tau) of belantamab mafodotin antibody drug conjugate (ADC)

  Up to 3 weeks

• Maximum observed plasma concentration (Cmax) of belantamab mafodotin ADC

  Up to 3 weeks

• Concentration at end of infusion (C-EOI) of belantamab mafodotin ADC

  Up to 104 weeks

• Drug concentration reached prior to next dose (Ctrough) of belantamab mafodotin ADC

  Up to 104 weeks

• Time to reach Cmax (Tmax) of belantamab mafodotin ADC

  Up to 3 weeks

• Area under the plasma concentration-time curve from time 0 to 168 hours (AUC 0-168h) of microtubule inhibitor released from belantamab mafodotin (cys-mcMMAF)

  Up to 168 hours

• Area under the plasma concentration-time curve from time 0 to 240 hours (AUC 0-240h) of cys-mcMMAF

  Up to 240 hours

• Cmax of cys-mcMMAF

  Up to 3 weeks

• Tmax of cys-mcMMAF

  Up to 3 weeks

Secondary Outcomes (7)

• Number of participants with adverse events (AEs) and serious AEs by severity

  Up to 252 weeks

• Number of participants with AEs leading to dose modifications or study intervention discontinuation

  Up to 252 weeks

• Number of participants with changes in visual acuity (VA) and corneal findings by severity as assessed by Keratopathy Visual Acuity scale (KVA) scale

  Up to 252 weeks

• Number of participants with ocular AEs by severity as assessed by Common terminology criteria for adverse events (CTCAE)

  Up to 252 weeks

• Number of participants with thrombocytopenic events by severity

  Up to 252 weeks

Study Arms (2)

Normal hepatic function

EXPERIMENTAL

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

Moderate hepatic impairment

EXPERIMENTAL

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

Interventions

Belantamab mafodotin DRUG

Belantamab mafodotin will be administered.

Moderate hepatic impairment; Normal hepatic function

Bortezomib DRUG

Bortezomib will be administered.

Moderate hepatic impairment; Normal hepatic function

Dexamethasone DRUG

Dexamethasone will be administered.

Moderate hepatic impairment; Normal hepatic function

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 MM, as defined by the International Myeloma Working Group (IMWG).
• Previously treated with at least 1 prior line of MM therapy and must have documented disease progression during or after their most recent therapy.
• Has at least 1 aspect of measurable disease, defined as at least 1 of the following:
• Urine M-protein excretion ≥200 milligram (mg)/24 hours (≥0.2 gram \[g\]/24 hours)
• Serum M-protein concentration ≥0.5 g/ deciliter (dL) (≥5.0 g/L)
• Serum Free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65).
• Plasmacytoma measurable as per IMWG criteria
• Bone Marrow infiltration by plasma cells \>30%
• For those participants with a history of autologous stem cell transplant, they 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 National Cancer Institute Common terminology criteria for adverse events \[NCI-CTCAE\] v5.0) must be Grade ≤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.
• Female participants are eligible to participate if they are not pregnant or breastfeeding and meet additional requirements.
• Is capable of giving signed informed consent including compliance with the requirements and restrictions listed in the ICF and protocol.
• Has adequate organ function for hematological and renal function tests.

You may not qualify if:

• Has an active plasma cell leukemia at the time of screening, symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or Waldenström macroglobulinemia.
• Has a previous or concurrent invasive malignancy other than MM, except for any other disease from which the participant must be considered medically stable for at least 1 year; 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 drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
• Has evidence of active mucosal or internal bleeding.
• Has a systemic active infection requiring treatment.
• Has had any major surgery (other than bone-stabilizing surgery) within 28 days prior to the first dose of study treatment.
• Has current corneal epithelial disease except for mild superficial keratopathy.
• Has any serious and/or unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.
• Has any history of prior allogenic stem cell transplant. Participants who have undergone syngeneic transplant will be allowed only if no history of or no currently active graft versus host disease.
• Has received prior belantamab mafodotin therapy if given within the last 90 days.
• Has received treatment with an investigational agent within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody and any other B-cell maturation antigen (BCMA) targeting therapy. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 mg/day for a maximum of 4 days) before treatment.
• Has received treatment with an inhibitor of Organic anion transporting polypeptide (OATP)1B1 or OATP1B3 within 14 days, preceding the first dose of study drug.
• Has received plasmapheresis within 7 days prior to the first dose of study treatment. Screening laboratory values must be performed after last plasmapheresis.
• Has a known HIV infection, unless the participant meets all of the following criteria:
• Established Anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/milliliter (mL) prior to first dose.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; 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

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 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): October 23, 2026
• Primary Completion (Estimated): August 22, 2031
• Study Completion (Estimated): August 22, 2031
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share