OncoMatch/Clinical Trials/NCT05853965
Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma
Is NCT05853965 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Belantamab mafodotin, Venetoclax for multiple myeloma.
Treatment: Belantamab mafodotin, Venetoclax — The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed/refractory multiple myeloma bearing the translocation t(11;14)
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: CCND1 t(11;14)
Cytogenetics/FISH confirming t(11;14)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
All patients have to have received at least one proteasome inhibitor
Must have received: immunomodulatory agent
All patients have to have received at least one immunomodulatory agent
Must have received: anti-CD38 monoclonal antibody
All patients have to have received at least one anti-CD38 monoclonal antibody
Cannot have received: BCL2 inhibitor (venetoclax)
Subject has received prior Venetoclax
Cannot have received: anti-BCMA therapy
Subject has received prior anti BCMA treatment
Cannot have received: allogeneic stem cell transplant
Participants who have had prior allogeneic stem cell transplant
Lab requirements
Blood counts
Hemoglobin ≥8.0 g/dL (without transfusion for past 14 days); ANC ≥ 1.5 x10^9/L (without growth factor support for past 14 days); Platelet count ≥75 x10^9/L (without growth factor or platelet stimulating agents for past 14 days)
Kidney function
eGFR ≥30 mL/min/1.73 m2 (MDRD formula); spot urine albumin/creatinine ratio <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
AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤ 1.5 x ULN). Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
Subjects must have adequate organ function, defined as: Hemoglobin ≥8.0 g/dL...AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN...eGFR ≥30 mL/min/1.73 m2...spot urine albumin/creatinine ratio <500 mg/g...Corrected serum calcium ≤ 14 mg/dL (≤3.5 mmol/L); or free ionized calcium < 6.5 mg/dL (<1.6 mmol/L)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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