Comparing Belantamab mafodotin with Daratumumab for multiple myeloma
Official title: A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
- Phase 3
- 2 groups
- One site, in Saint John
- Recruiting
Interventions (4)
- Medication
Belantamab mafodotin
Belantamab mafodotin will be administered.
- Medication
Lenalidomide
Lenalidomide will be administered.
- Medication
Dexamethasone
Dexamethasone will be administered.
- Medication
Daratumumab
Daratumumab will be administered.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
GSK Investigational Site
Saint John, New Brunswick
Eligibility Criteria
See who this study is looking for52 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- +Is at least 18 or the legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
- +Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocolProtocolThe detailed plan a study must follow.Read more →.
- +NDMM with a requirement for treatment as documented per IMWG criteria.
- +Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following:
- +Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or
- +Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or
- +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).
- +ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → from treatment with ASCT due to country- or siteTrial siteA hospital or clinic where a study is actually run.Read more →-specific age restriction.
- +Adequate organ system function as defined by the laboratory assessments.
- +Male participants:
- +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 study intervention to allow for clearance of any altered sperm:
- +Refrain from donating fresh unwashed semen
- +PLUS either:
- +Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
- +Female participants
- +Is not a WOCBP OR
- +Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- +Must agree to use contraception/barrier as detailed below
- +Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.
- +Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- +A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
- +Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- +A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention.
- +Should pregnancy occur in a female on treatment or the female partner of a male on treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology.
- +Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following:
- +Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT.
Exclusion
- −Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study intervention.
- −Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
- −Established antiretroviral therapy for at least 4 weeks and HIV viral load \<400 copies/mL within Screening PeriodScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention unless the participant can meet the following criteria:
- −Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C viral load RNA test after a washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → of at least 4 weeks.
- −Participants with hepatitis B will be excluded unless the defined criteria can be met.
- −Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \>5%).
- −Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma.
- −Signs of meningeal or central nervous system involvement with multiple myeloma.
- −Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, or compliance with study procedures.
- −Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s assessment).
- −Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are any other malignancy that has been considered medically stable for at least 2 years, after discussion with the GSK Medical Monitor. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
- −Evidence of cardiovascular risk including any of the following:
- −Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block.
- −Recent history (within 3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty or stenting, or bypass grafting.
- −Class III or IV heart failure as defined by the New York Heart Association functional classification system.
- −CD4+ T-cell (CD4+) counts ≥350 cells/μL.
- −No history of acquired immune deficiency syndrome-defining opportunistic infections within the last 12 months.
- −RNA test negative.
- −Current corneal epithelial disease except for mild punctate keratopathy.
- −Intolerance or contraindications to antiviral prophylaxis.
- −Unable to tolerate antithrombotic prophylaxis.
- −Plasmapheresis within 7 days prior to the first dose of study intervention.
- −Participants must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.
- −Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Belantamab mafodotin, Lenalidomide and Dexamethasone.
Registry label: A: Arm A: Belantamab Mafodotin + Lenalidomide + Dexamethasone
Group B, the comparison group, receives Daratumumab, Lenalidomide and Dexamethasone.
Registry label: B: Arm B: Daratumumab + Lenalidomide + Dexamethasone
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 520 people.
The study is currently expected to finish around April 2031.
The main measurement is taken over: Up to approximately 7 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
PFS — measured over Up to approximately 7 years.
Number of Participants Achieving MRD Negative Status — measured over Up to approximately 7 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06679101 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Belantamab mafodotinDrug
Belantamab mafodotin will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LenalidomideDrug
Lenalidomide will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DexamethasoneDrug
Dexamethasone will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DaratumumabDrug
Daratumumab will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 7 years.
The study as a whole is currently expected to finish around 2031-04-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 520 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Saint John, New Brunswick, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Billings, Montana, United States; New York, New York, United States; Stony Brook, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.
Other Sites (6)
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Billings, Montana, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Stony Brook, New York, United States
GSK Investigational Site
Puyallup, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.