OncoMatch/Clinical Trials/NCT05847569
Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Is NCT05847569 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Belantamab Mafodotin for recurrent multiple myeloma.
Treatment: Belantamab Mafodotin — This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor (bortezomib, carfilzomib, ixazomib)
Has had disease progression after >= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib)
Must have received: immunomodulatory agent (thalidomide, lenalidomide, pomalidomide)
Has had disease progression after >= 3 prior lines of anti-myeloma treatments including one immunomodulatory agent (eg.thalidomide, lenalidomide or pomalidomide)
Must have received: anti-CD38 monoclonal antibody (daratumumab, isatuximab)
Has had disease progression after >= 3 prior lines of anti-myeloma treatments including one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab)
Cannot have received: antibody-drug conjugate (belantamab mafodotin)
Prior belantamab mafodotin therapy
Cannot have received: allogeneic stem cell transplant
Patients who received prior allogeneic stem cell transplant
Lab requirements
Blood counts
Absolute neutrophil count >= 0.75 x 10^9/L (without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin); Hemoglobin >= 7.0 g/dL (without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin); Platelets >= 50 x 10^9/L (without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin)
Kidney function
Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 (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)]
Liver function
Total bilirubin <= 2.0 x ULN (>= 2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%); Alanine aminotransferase <= 2.5 x ULN; Aspartate transaminase <= 2.5 x ULN
Cardiac function
No evidence of cardiovascular risk, including: current clinically significant untreated arrhythmias, clinically significant ECG abnormalities (2nd degree [Mobitz type II] or 3rd degree 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 (NYHA), uncontrolled hypertension
Absolute neutrophil count >= 0.75 x 10^9/L... Hemoglobin >= 7.0 g/dL... Platelets >= 50 x 10^9/L... Total bilirubin <= 2.0 x ULN... Alanine aminotransferase <= 2.5 x ULN... Aspartate transaminase <= 2.5 x ULN... eGFR >= 30 mL/min/1.73 m^2... Spot urine [albumin/creatinine ratios (spot urine)] <= 500 mg/g... No evidence of cardiovascular risk, including: current clinically significant untreated arrhythmias, clinically significant ECG abnormalities (2nd degree [Mobitz type II] or 3rd degree 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 (NYHA), uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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