OncoMatch/Clinical Trials/NCT05060627
Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
Is NCT05060627 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Belantamab mafodotin and Carfilzomib for relapsed multiple myeloma.
Treatment: Belantamab mafodotin · Carfilzomib · Dexamethasone — This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients. Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.
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: lenalidomide (lenalidomide)
Patients must be refractory to lenalidomide. Refractoriness is defined as progression while receiving lenalidomide or in the first 60 days after the last dose of lenalidomide.
Cannot have received: anti-BCMA agent
Participant has received prior treatment with anti-BCMA agents.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 X 10^9/L; Hemoglobin ≥8.0 g/dL (prior RBC transfusion or recombinant human erythropoietin use is permitted); Platelets ≥75 x 10^9/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count >50 × 10^9/L (prior platelet transfusion is permitted up to 7 days before the screening phase); Calcium corrected serum calcium <14 mg/dL (<3.5 mmol/L); or free ionized calcium <6.5 mg/dL (<1.6 mmol/L)
Kidney function
eGFR ≥40 mL/min/1.73 m2; Spot urine (albumin/creatinine ratios) <500 mg/g (56 mg/mmol) OR Negative/trace (if ≥1+ only eligible if confirmed ≥ 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) Urine Dipstick
Liver function
Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); ALT ≤2.5 X ULN; AST ≤2.5 X ULN
Cardiac function
LVEF (echo) ≥ 40%
Participant must have adequate organ function. Laboratory values that define adequate organ function for inclusion in study are as follow: HEMATOLOGIC... HEPATIC... RENAL... CARDIAC...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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