Belantamab Mafodotin for Triple-Class Refractory Multiple Myeloma
This study is looking at different doses and schedules of belantamab mafodotin for people with multiple myeloma that has come back (recurrent) or hasn't responded to previous treatments (refractory). Belantamab mafodotin is a targeted therapy. It works by attaching to specific molecules called BCMA receptors on cancer cells, delivering a chemotherapy drug to kill them. The main goal is to see how well patients tolerate the treatment, specifically looking at a side effect called keratopathy (eye problems) at the time of the fourth dose. You might be able to join if you are 18 or older, have a certain performance status, and have been diagnosed with multiple myeloma that meets specific criteria. The study is currently unclear about its recruitment status.
- Study design
- This is an interventional study planning to enroll 62 participants. It is testing different doses and schedules of belantamab mafodotin.
- What's involved
- You would receive belantamab mafodotin intravenously (IV) and undergo blood sample collections, bone marrow aspirates, bone marrow biopsies, and CT scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at the time of dose 4. Other outcomes like survival are also assessed, but specific follow-up duration is not detailed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05847569
Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~62 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Belantamab MafodotinBiospecimen CollectionBone Marrow AspirateBone Marrow BiopsyComputed TomographyMagnetic Resonance Imaging
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade 3/4 keratopathy-free rate
Measured over At the time of dose 4
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Ricardo D. Parrondo, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined in International Myeloma Working Group (IMWG) criteria, and:
If patients have undergone stem cell transplantation (SCT), day 0 of SCT must be \> 100 days prior to registration to be eligible for the study
Has had disease progression after \>= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib), one immunomodulatory agent (eg.thalidomide, lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab)
Prior non-belantamab mafodotin anti-BCMA agent exposure is allowed; patients with prior treatment with an anti-BCMA chimeric antigen receptor (CAR)-T or bispecific antibody will be allowed to participate in the study
Has measurable disease with at least one of the following:
Serum M-protein \>= 0.5 g/dL (\>= 5 g/L)
Urine M-protein \>= 200 mg/24 h
Serum free light chain (FLC) assay: Involved FLC level \>= 10 mg/dL (\>= 100 mg/L) and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65)
Note: Patients with non-secretory disease will be allowed to participate
Absolute neutrophil count \>= 0.75 x 10\^9/L (=\< 28 days prior to registration)
Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
Hemoglobin \>= 7.0 g/dL (=\< 28 days prior to registration)
Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
Platelets \>= 50 x 10\^9/L (=\< 28 days prior to registration)
Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
Total bilirubin =\< 2.0 x upper limit of normal (ULN) (=\< 28 days prior to registration); (total bilirubin \>= 2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%)
Alanine aminotransferase =\< 2.5 x ULN (=\< 28 days prior to registration)
Aspartate transaminase =\< 2.5 x ULN (=\< 28 days prior to registration)
Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 (=\< 28 days prior to registration)
As calculated by Modification of Diet in Renal Disease (MDRD) formula
Spot urine \[albumin/creatinine ratios (spot urine)\] =\< 500 mg/g (56 mg/mmol) OR urine dipstick negative/trace \[if \>1+ only eligible if confirmed =\< 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void)\] (=\< 28 days prior to registration)
Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only. Both females and males must agree to follow the instructions
NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Provide written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol
Willingness to provide mandatory blood specimens for correlative research
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Exclusion
Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom Macroglobulinemia
Prior belantamab mafodotin therapy. However, patients with prior exposure to another non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA bispecific antibody will be allowed to participate in the study
Systemic active infection requiring treatment
Any unresolved toxicity \>= grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to grade 2
Any major surgery =\< 4 weeks prior to registration
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures
Evidence of active mucosal or internal bleeding
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria
Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the prior malignancy has been considered medically stable for \> 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. NOTE: Participants with curatively treated nonmelanoma skin cancer are allowed without a 2-year restriction.
Evidence of cardiovascular risk, including any of the following:
Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz type II) or 3rd degree atrioventricular (AV) block
History of myocardial infarction (=\< 6 months), acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 12 weeks of screening
Class III or IV heart failure as defined by the New York Heart Association functional classification system \[NYHA, 1994\]
Uncontrolled hypertension
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
Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
Established anti-retroviral therapy (ART) for at \>=4 weeks and HIV viral load \< 400 copies/mL
CD4+ T-cell (CD4+) counts \>= 350 cells/uL
No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections \< 12 months prior
Note: consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant
Patients with hepatitis B will be excluded unless the following criteria can be met:
If patient's serology shows hepatitis B virus core antibody (HbcAb)+ and hepatitis B surface antigen (HbsAg)-, they must have undetectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening. Patients will be monitored per protocol. Antiviral treatment would be instituted if HBV DNA becomes detectable
If patient's serology shows HBsAg+ at screen or within 3 months prior, patients must have undetectable HBV DNA at screening, must have started highly effective antiviral treatment at least 4 weeks prior to registration, and must have baseline imaging per protocol (patients with cirrhosis are excluded). Patients must remain on antiviral treatment throughout the study. Patients will be monitored per protocol
Note: presence of hepatitis (Hep) B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or =\< 12 weeks prior to first dose of study treatment unless the participant can meet the following criteria:
RNA test negative
Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period \>= 4 weeks
Current corneal epithelial disease except for mild punctuate keratopathy
Participant who received plasmapheresis within =\< 7 days prior to registration
Patients who received prior allogeneic stem cell transplant
Participant who received a live or live-attenuated vaccine =\< 30 days prior to registration. Ok to receive coronavirus disease (COVID) vaccine at any timepoint during protocol treatment
Participant is a woman who is pregnant or lactating
Participant who plans on wearing contact lenses during treatment with belantamab mafodotin
What this trial measures
- Grade 3/4 keratopathy-free rateAt the time of dose 4
The proportion of successes will be estimated by the number of successes (proportion of patients free of grade 3/4 keratopathy at the time of dose #4) divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If both arms prove to meet the primary endpoint, they will be evaluated indirectly in relation to each other similar, to a Bayesian pick the winner, approach if only one can be brought forward for further testing