A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Partic… (NCT07609706) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
20 participantsStarted 2026-10-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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%
Exclusion criteria
. Established Anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/milliliter (mL) prior to first dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Up to 3 weeks
2
Maximum observed plasma concentration (Cmax) of belantamab mafodotin ADC
Timeframe: Up to 3 weeks
3
Concentration at end of infusion (C-EOI) of belantamab mafodotin ADC
Timeframe: Up to 104 weeks
4
Drug concentration reached prior to next dose (Ctrough) of belantamab mafodotin ADC
Timeframe: Up to 104 weeks
5
Time to reach Cmax (Tmax) of belantamab mafodotin ADC
Timeframe: Up to 3 weeks
6
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)
Timeframe: Up to 168 hours
7
Area under the plasma concentration-time curve from time 0 to 240 hours (AUC 0-240h) of cys-mcMMAF
. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.
. 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.