All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bor… (NCT06956170) | Clinical Trial Compass
Active — Not RecruitingPhase 3
All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
Japan21 participantsStarted 2022-02-10
Plain-language summary
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).
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.
Inclusion criteria
. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than \[\<\]0.26 or greater than \[\>\]1.65) only if participant has no measurable urine or serum M spike.
Exclusion criteria
. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
. Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
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.
1This trial is specifically enrolling Japanese patients — does my background and where I receive care make me eligible to even be considered for this kind of study?
2The trial is now 'active but not recruiting,' which means they've stopped enrolling new patients — does that mean this specific trial is closed to me, and are there similar trials comparing belantamab mafodotin combinations that are still open?
3Belantamab mafodotin is known to cause eye-related side effects like blurry vision or corneal damage — how significant is that risk in a combination regimen like this, and how would it affect my day-to-day life if I were on it?
4Since this is a Phase 3 trial measuring progression-free survival, how does the evidence so far for this belantamab mafodotin combination compare to what we already know about bortezomib plus pomalidomide and dexamethasone, which is the other treatment arm in the study?
5Given that my myeloma has relapsed or is refractory, would you recommend I pursue a standard approved treatment first, or is a trial like this one — or something similar — worth prioritizing at this stage of my disease?
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.