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OncoMatch/Clinical Trials/NCT05002816

Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma

Is NCT05002816 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Elotuzumab and Belantamab mafodotin for multiple myeloma.

Phase 1/2RecruitingYale UniversityNCT05002816Data as of May 2026

Treatment: Elotuzumab · Belantamab mafodotinThe purpose of this research study is to determine if two drugs approved for treating multiple myeloma, belantamab mafodotin and elotuzumab, are safe and more effective when used together.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 3 prior lines

Must have received: immunomodulatory drug

Prior line of therapy must include iMID

Must have received: proteasome inhibitor

Prior line of therapy must include ... proteasome inhibitor

Must have received: anti-CD38 monoclonal antibody

Prior line of therapy must include ... anti-CD38 monoclonal antibody

Cannot have received: monoclonal antibody

Exception: prior elotuzumab is allowed

Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs

Cannot have received: systemic anti-myeloma therapy

Exception: systemic steroids are allowed

Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (systemic steroids are allowed) within 14 days preceding the first dose of study drug

Cannot have received: plasmapheresis

Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment

Cannot have received: major surgery

Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment

Lab requirements

Blood counts

ANC ≥0.5X 10^9/L; Hemoglobin ≥8.0 g/dL; Platelets ≥50X 10^9/L

Kidney function

eGRF ≥30 mL/min/ 1.73 m2; Spot urine (albumin/creatinine ratios) <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 ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); ALT ≤2.5 X ULN

Participant must have adequate organ function, defined as: ANC ≥0.5X 10 9/L; Hemoglobin ≥8.0 g/dL; Platelets ≥50X 10 9/L; Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); ALT ≤2.5 X ULN; eGRF ≥30 mL/min/ 1.73 m2; Spot urine (albumin/creatinine ratios) <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))

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Yale New Haven Hospital · New Haven, Connecticut

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