Multiple MyelomaPhase 1NCT07609706
A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
A Phase 1 study testing Belantamab mafodotin, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Belantamab mafodotin, Bortezomib and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 22 Aug 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
- Has specific hepatic function ranges for serum bilirubin and AST for Group 1 and Group 2.
- Participants in Group 1 (normal hepatic function) will only be enrolled if they match a participant in Group 2 (moderate hepatic impairment). Each Group 1/Group 2 pair will be matched based on the Group 2 participant's baseline body weight (±20%).
- Participants with a history of Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) and Human immunodeficiency virus (HIV) exposure are eligible under specific conditions
Who cannot join
- 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.
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- 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 received any live vaccine within 30 days of enrollment. Vaccination against COVID-19 using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.
- 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.
- Has CD4+ T-cell count values ≥350 cells/L
- No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.
- Is pregnant, plans to become pregnant, or is breastfeeding.
- Has Gilbert's syndrome.
- Has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice in the last 14 days prior to the first dose.
- Has documented presence of Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to the first dose of study intervention. Participants with hepatitis B will be excluded unless the specific protocol criteria are met.
- Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to the first dose of study intervention unless HCV ribonucleic acid (RNA) is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment, unless specific protocol criteria are met
- Has a positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.
- Evidence of cardiovascular risk including any of the following:
- Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third degree atrioventricular block.
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Uncontrolled hypertension.
- Has QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
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
- Being tested
- Belantamab mafodotin, Bortezomib, Dexamethasone
- Keywords
- Multiple Myeloma, Hepatic Impairment, Bortezomib, Dexamethasone, Belantamab mafodotin
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belantamab mafodotinDrug
Belantamab mafodotin will be administered.
BortezomibDrug
Bortezomib will be administered.
DexamethasoneDrug
Dexamethasone will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Normal hepatic function | Experimental | Not described Receives: Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Dexamethasone |
| Moderate hepatic impairment | Experimental | Not described Receives: Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 3 weeks
Maximum observed plasma concentration (Cmax) of belantamab mafodotin ADC
Measured: Up to 3 weeks
Concentration at end of infusion (C-EOI) of belantamab mafodotin ADC
Measured: Up to 104 weeks
Drug concentration reached prior to next dose (Ctrough) of belantamab mafodotin ADC
Measured: Up to 104 weeks
Time to reach Cmax (Tmax) of belantamab mafodotin ADC
Measured: 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)
Measured: Up to 168 hours
Area under the plasma concentration-time curve from time 0 to 240 hours (AUC 0-240h) of cys-mcMMAF
Measured: Up to 240 hours
Cmax of cys-mcMMAF
Measured: Up to 3 weeks
Tmax of cys-mcMMAF
Measured: Up to 3 weeks
Secondary outcomes (7)
Number of participants with adverse events (AEs) and serious AEs by severity
Measured: Up to 252 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Measured: 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
The Keratopathy-Visual Acuity (KVA) scale is a 0-4 grading system used to assess the severity of keratopathy and its impact on visual acuity. Higher grades reflect increasing severity of corneal findings and visual acuity loss.
Measured: Up to 252 weeks
Number of participants with ocular AEs by severity as assessed by Common terminology criteria for adverse events (CTCAE)
Measured: Up to 252 weeks
Number of participants with thrombocytopenic events by severity
Measured: Up to 252 weeks
Change from baseline in clinical laboratory parameter: serum bilirubin (milligrams per decilitre[mg/dl])
Measured: Baseline (Day 1) and up to 252 weeks
Change from baseline in clinical laboratory parameter: AST and ALT (International Units per litre [IU/L])
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) will be analysed. Both parameters have same unit of measure.
Measured: Baseline (Day 1) and up to 252 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start23 Oct 2026 (estimated)
- Primary completion22 Aug 2031 (estimated)
- Study completion22 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609706
- Sponsor's protocol ID
- 308247
- Other IDs
- 2026-526725-18-00
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
- ClinicalTrials.gov ID
- NCT07609706
- Acronym / sponsor ID
- 308247
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Hepatic Impairment, Bortezomib, Dexamethasone, Belantamab mafodotin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 22 Aug 2031 (estimated)
- Study completion
- 22 Aug 2031 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal hepatic function | Experimental | Drug: Belantamab mafodotin, Drug: Bortezomib, Drug: Dexamethasone |
| Moderate hepatic impairment | Experimental | Drug: Belantamab mafodotin, Drug: Bortezomib, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotinBelantamab mafodotin will be administered. | Drug | Moderate hepatic impairment, Normal hepatic function |
| BortezomibBortezomib will be administered. | Drug | Moderate hepatic impairment, Normal hepatic function |
| DexamethasoneDexamethasone will be administered. | Drug | Moderate hepatic impairment, Normal hepatic function |
Primary outcome
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)
Time frame: Up to 3 weeks
Maximum observed plasma concentration (Cmax) of belantamab mafodotin ADC
Time frame: Up to 3 weeks
Concentration at end of infusion (C-EOI) of belantamab mafodotin ADC
Time frame: Up to 104 weeks
Drug concentration reached prior to next dose (Ctrough) of belantamab mafodotin ADC
Time frame: Up to 104 weeks
Time to reach Cmax (Tmax) of belantamab mafodotin ADC
Time frame: 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)
Time frame: Up to 168 hours
Area under the plasma concentration-time curve from time 0 to 240 hours (AUC 0-240h) of cys-mcMMAF
Time frame: Up to 240 hours
Cmax of cys-mcMMAF
Time frame: Up to 3 weeks
Tmax of cys-mcMMAF
Time frame: Up to 3 weeks
7 secondary outcomes
Number of participants with adverse events (AEs) and serious AEs by severity
Time frame: Up to 252 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time frame: 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
Time frame: Up to 252 weeks
Number of participants with ocular AEs by severity as assessed by Common terminology criteria for adverse events (CTCAE)
Time frame: Up to 252 weeks
Number of participants with thrombocytopenic events by severity
Time frame: Up to 252 weeks
Change from baseline in clinical laboratory parameter: serum bilirubin (milligrams per decilitre[mg/dl])
Time frame: Baseline (Day 1) and up to 252 weeks
Change from baseline in clinical laboratory parameter: AST and ALT (International Units per litre [IU/L])
Time frame: Baseline (Day 1) and up to 252 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belantamab mafodotin, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.