OncoMatch/Clinical Trials/NCT05573802
A Study to Investigate Safety and Clinical Activity of Belantamab Mafodotin in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma
Is NCT05573802 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Belantamab Mafodotin-Blmf and Lenalidomide for multiple myeloma.
Treatment: Belantamab Mafodotin-Blmf · Lenalidomide · Dexamethasone · Nirogacestat — This is a phase 1/2, open-label study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with lenalidomide, dexamethasone and nirogacestat in patients with transplant ineligible newly diagnosed multiple myeloma. This will be a 2-part study. In part 1 participants will be enrolled in one cohort to receive belantamab mafodotin in combination with lenalidomide, dexamethasone and nirogacestat and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used in future studies in the transplant-ineligible newly diagnosed multiple myeloma (NDMM) setting. In the dose expansion phase (Part 2) an expansion cohort will be treated with the RP2D. The expansion cohort will randomize participants (1:1) in two groups to evaluate two alternate dose modification guidelines for corneal AEs. Part 2 of the study will also evaluate an alternative dose modification guideline for corneal adverse events (AEs). Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is enrolled (follow-up period range: 3-4 years). The estimated accrual period will be 12 months, corresponding to an approximate total study duration of 4 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: emergency course of steroids (≤40 mg dexamethasone per day for max 4 days) permitted; focal palliative radiation permitted if ≥2 weeks before first dose and recovered from toxicities
Prior systemic therapy for MM or Smoldering MM
Cannot have received: gamma secretase inhibitor
previous administration of a gamma secretase inhibitor
Lab requirements
Blood counts
ANC ≥1.25 x 10^9/L (no G-CSF in past 14 days); Hemoglobin ≥8.0 g/dL (no transfusions in past 14 days, erythropoietin allowed); Platelet count ≥50 x 10^9/L if BM >50% involved, otherwise ≥75 x 10^9/L (no transfusions or platelet stimulating agents in past 14 days).
Kidney function
eGFR ≥30 mL/min/1.73 m2 (MDRD formula); Spot urine (albumin/creatinine ratio) <500 mg/g OR Urine Dipstick: Negative trace; if ≥1+ only eligible if confirmed <500 mg/g by albumin/creatinine ratio (spot urine from first void).
Liver function
Total bilirubin ≤1.5xULN (isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). ALT ≤2.5xULN.
Adequate organ system function as defined by the below laboratory assessments. Hematologic: ANC ≥1.25 X 10^9/L; Hemoglobin ≥8.0 g/dL; Platelet count ≥50 x 10^9/L if the BM is >50% involved in myeloma. Otherwise, ≥75 x 10^9/L. Hepatic: Total bilirubin ≤1.5xULN... ALT ≤2.5xULN. Renal: eGFR ≥30 mL/min/1.73 m2; Spot urine (albumin/creatinine ratio) <500 mg/g OR Urine Dipstick: Negative trace; if ≥1+ only eligible if confirmed <500 mg/g by albumin/creatinine ratio (spot urine from first void).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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